| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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052
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Date of Entry 07/15/2019
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FR Recognition Number
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6-129
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| Standard | |
| ISO 594-2 Second edition 1998-09-01 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings |
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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Transition Period
| FDA recognition of ISO 594-1 First edition 1986-06-15 [Rec# 6-11] and ISO 594-2 Second edition 1998-09-01 [Rec# 6-129] will be superseded by recognition of ISO 80369-7 Second edition 2020-12 [Rec# 5-133]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-11] and [Rec# 6-129] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 6-11] and [Rec# 6-129] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §880.5570 |
Needle, Hypodermic, Single Lumen |
Class 2 |
FMI |
| §880.5860 |
Syringe, Antistick |
Class 2 |
MEG |
| §880.5860 |
Syringe, Piston |
Class 2 |
FMF |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance on the Content of Premarket Notification [510(k)] Submissions for Hypodermic Single Lumen Needles. Issued April 1993
Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes. Issued April 1993
Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features. Issued August 9, 2005 |
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| FDA Technical Contacts
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| Standards Development Organization
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FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
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| *These are provided as examples and others may be applicable. |
