| |
| Trade Name | DERMABOND TOPICAL SKIN ADHESIVE |
| Classification Name | tissue adhesive for the topical approximation of skin |
| Generic Name | topical tissue adhesive |
| Regulation Number | 878.4010 |
| Applicant | CLOSURE MEDICAL CORP. |
| PMA Number | P960052 |
| Supplement Number | S009 |
| Date Received | 08/19/2004 |
| Decision Date | 09/24/2004 |
| Product Code | |
| Advisory Committee |
General & Plastic Surgery |
| Supplement Type | normal 180 day track no user fee |
| Supplement Reason | location change: sterilizer |
| Expedited Review Granted? | No |
| Combination Product |
No
|
Approval Order Statement Approval for an additional sterilization facility and to another known method of sterilization located at sterigenics (formerly iba/griffith), charlotte, north carolina. |