The following data is part of a premarket notification filed by Lifelink Foundation Tissue Bank with the FDA for Dura Mater.
| Device ID | K910447 |
| 510k Number | K910447 |
| Device Name: | DURA MATER |
| Classification | Human Lyophilized Dura Mater |
| Applicant | LIFELINK FOUNDATION TISSUE BANK 8510 SUNSTATE ST. Tampa, FL 33634 |
| Contact | Dave Shires |
| Correspondent | Dave Shires LIFELINK FOUNDATION TISSUE BANK 8510 SUNSTATE ST. Tampa, FL 33634 |
| Product Code | LEM |
| CFR Regulation Number | 882.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-18 |
| Decision Date | 1992-06-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DURA MATER 75892159 2580740 Dead/Cancelled |
Dura Mater, Inc. 2000-01-07 |