|
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 | S009 |
Date Received | 08/19/2004 |
Decision Date | 09/24/2004 |
Reclassified Date
|
05/05/2008 |
Product Code |
MPN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
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. |