Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-268: ASTM F921-10 (Reapproved 2011), Standard Terminology Relating to Hemostatic Forceps. (General Plastic Surgery/General Hospital)
Date of Standard: 2010. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
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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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| (3) | OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB) |
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| Devices Affected: |
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| Processes Affected: |
| Premarket Notification, GMP, Design Controls and MDR Review |
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| Type of Standard: |
| Vertical, National |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.4565 |
Hemostat, Surgical |
Class 1 |
EMD |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §878.4800 |
Forceps |
Class 1 |
HTD |
| §878.4800 |
Forceps, General & Plastic Surgery |
Class 1 |
GEN |
| |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Long Chen, Ph.D. |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1461 |
| Silver Spring MD 20993 |
| 301/796-6389 |
| Email: long.chen@fda.hhs.gov |
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