|
Device | DERMABOND TOPICAL SKIN ADHESIVE |
Generic Name | Tissue adhesive for the topical approximation of skin |
Regulation Number | 878.4010 |
Applicant | CLOSURE MEDICAL CORP. 5265 CAPITAL BLVD. RALEIGH, NC 27616 |
PMA Number | P960052 |
Supplement Number | S012 |
Date Received | 08/16/2006 |
Decision Date | 09/14/2006 |
Reclassified Date
|
05/05/2008 |
Product Code |
MPN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO THE STERILIZATION PROCESS. |