|
Trade Name | COMPOSITE CULTURED SKIN |
Classification Name | dressing, wound and burn, interactive |
Generic Name | dressing, wound and burn, interactive |
Applicant |
ORTEC INTL., INC. |
3960 broadway, 2nd flr. |
new york, NY 10032 |
|
HDE Number | H990013 |
Supplement Number | S001 |
Date Received | 05/23/2001 |
Decision Date | 06/14/2001 |
Product Code | |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Modify product manufacture to include fibroblast cells (bs143f05) expanded to passage 4. |