Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-277: ISO 11040-4 Second edition 2007-02-01, Prefilled syringes - Part 4: Glass barrels for injectables. (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 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: |
| All medical device glass barrels used in the delivery of parenteral pharmaceutical products |
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| Processes Affected: |
| 510(k), PMA, IDE, Pre-IDE, HDE, GMP, Design Controls |
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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 |
Injector, Pen |
Class 2 |
NSC |
| §880.5860 |
Syringe, Antistick |
Class 2 |
MEG |
| §880.5860 |
Syringe, Piston |
Class 2 |
FMF |
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| Relevant Guidance: |
| FDA Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes |
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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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