Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-204: ISO 8537 Second edition 2007-10-01, Sterile single-use syringes, with or without needle, for insulin. (General Plastic Surgery/General Hospital)
Date of Standard: 2007. |
| 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: |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE |
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| Type of Standard: |
| Vertical, International |
| 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, Piston |
Class 2 |
FMF |
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| Relevant Guidance: |
| Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes. Issued April 1993 |
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| FDA Technical Contact: |
| Patricia Beaston |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2536 |
| Silver Spring MD 20993 |
| 301/796-3155 |
| Email: patricia.beaston@fda.hhs.gov |
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