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 |