The following data is part of a premarket notification filed by Tissue Science Laboratories, Plc with the FDA for Permacol.
Device ID | K021056 |
510k Number | K021056 |
Device Name: | PERMACOL |
Classification | Mesh, Surgical |
Applicant | TISSUE SCIENCE LABORATORIES, PLC 555 THIRTEENTH ST. N.W. Washington, DC 20004 -1109 |
Contact | Howard M Holstein |
Correspondent | Howard M Holstein TISSUE SCIENCE LABORATORIES, PLC 555 THIRTEENTH ST. N.W. Washington, DC 20004 -1109 |
Product Code | FTM |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-04-01 |
Decision Date | 2002-10-31 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PERMACOL 76405739 2780496 Dead/Cancelled |
Paul Hartmann AG 2002-05-10 |
PERMACOL 75587937 2654649 Live/Registered |
COVIDIEN AG 1998-11-13 |
PERMACOL 72015862 0648764 Dead/Expired |
W. H. & L. D. BETZ (PARTNERSHIP) 1956-09-18 |