Recognition List Number: 013 Publication Date: 10/31/2005
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-11: ISO 594/1, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements. (General Plastic Surgery/General Hospital)
Date of Standard: 1986. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| All luer taper pistons syringes & hypodermic single lumen needles |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5570 |
Needle, Hypodermic, Single Lumen |
Class 2 |
FMI |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5860 |
Syringe, Antistick |
Class 2 |
MEG |
| §880.5860 |
Syringe, Piston |
Class 2 |
FMF |
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| Relevant Guidance: |
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 Contact: |
| Scott A. Colburn |
| FDA/CDRH/OCD |
| 10903 New Hampshire Avenue Building 66, Room 3628 |
| Silver Spring MD 20993 |
| 301/796-6287 |
| Email: scott.colburn@fda.hhs.gov |
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