HDE supplement
H990013 S001: COMPOSITE CULTURED SKIN
FDA HDE supplement · normal 75 day track · ORTEC INTL., INC.
Key facts
| Original HDE | H990013 |
|---|---|
| Supplement number | S001 |
| Supplement type | normal 75 day track |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | COMPOSITE CULTURED SKIN |
| Generic name | Dressing, wound and burn, interactive |
| Applicant | ORTEC INTL., INC. |
| Product code | MGR |
| Received date | May 23, 2001 |
| Decision date | Jun 14, 2001 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: