Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-292: ISO 7886-1:1993 TECHNICAL CORRIGENDUM 1, Published 1995-11-01 Sterile hypodermic syringes for singe-use - Part 1: Syringes for manual use. (General Plastic Surgery/General Hospital)
Date of Standard: 1995. |
| 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) | | DIV OF ANESTHESIOLOGY,GEN. HOSPITAL, INFECTION CONTROL & DENTAL DEVICE (DAGRID) |
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| Devices Affected: |
| All Manual Hypodermic Syringes |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, 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 |
| §880.5860 |
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: |
| Kathleen Fitzgerald |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2560 |
| Silver Spring MD 20993 |
| 301/796-6292 |
| Email: kathleen.fitzgerald@fda.hhs.gov |
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