Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-275: ISO 11608-2 Second edition 2012-04-01, Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles. (General Plastic Surgery/General Hospital)
Date of Standard: 2012. |
| 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 Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | |
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| (2) | OFFICE OF COMPLIANCE (OC) | | |
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| Devices Affected: |
| Pen injectors, Auto-injectors |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Quality System Regulation |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
| Complete standard and any annexes. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5860 |
Injector, Pen |
Class 2 |
NSC |
| §880.5860 |
Syringe, Antistick |
Class 2 |
MEG |
| §880.5860 |
Syringe, Piston |
Class 2 |
FMF |
| §880.5860 |
Syringe, Piston, Reprocessed |
Class 2 |
NKN |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.6920 |
Introducer, Syringe Needle |
Class 2 |
KZH |
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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: |
| Anthony D. Watson |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2516 |
| Silver Spring MD 20993 |
| 301/796-6296 |
| Email: anthony.watson@fda.hhs.gov |
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