|
Trade Name | ORCEL (TM) (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 | S004 |
Date Received | 10/22/2001 |
Decision Date | 02/06/2002 |
Product Code | |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Introduction of new cell line, fd-183, into the commercial manufacture of orcel bilayered cellular matrix. |