|
Device | SURGIFOAM ABSORBABLE GELATIN SPONGE |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | Ferrosan Meidcal Devices A/S Sydmarken 5 Soeborg 08876 |
PMA Number | P990004 |
Supplement Number | S023 |
Date Received | 10/22/2012 |
Decision Date | 01/09/2013 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 Review Track For 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE LOCATION OF THE FERROSAN MEDICAL DEVICES A/S (FEMD) TESTING LABORATORY IN SOEBORG, DENMARK. |