Recognition List Number: 018 Publication Date: 09/12/2007
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-185: ASTM F 881 -94 (Reapproved 2006), Standard Specification for Silicone Elastomer Facial Implants. (General Plastic Surgery/General Hospital)
Date of Standard: 2006. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
| |
|
| 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 |
|
| Type of Standard: |
| Horizontal, National |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Implant, Malar |
Class U |
LZK |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §878.3300 |
Mesh, Surgical, Polymeric |
Class 2 |
FTL |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §878.3550 |
Prosthesis, Chin, Internal |
Class 2 |
FWP |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §878.3590 |
Prosthesis, Otoplasty |
Class 2 |
ESY |
| §878.3590 |
Prosthesis, Ear, Internal |
Class 2 |
FZD |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §878.3680 |
Prosthesis, Nose, Internal |
Class 2 |
FZE |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| 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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