PERMACOL
Mesh, Surgical
TISSUE SCIENCE LABORATORIES, PLC
The following data is part of a premarket notification filed by Tissue Science Laboratories, Plc with the FDA for Permacol.
Pre-market Notification Details
| Device ID | K013625 |
| 510k Number | K013625 |
| 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 | 2001-11-05 |
| Decision Date | 2002-01-17 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521190702 | K013625 | 000 |
| 10884521190696 | K013625 | 000 |
| 10884521190689 | K013625 | 000 |
| 10884523000030 | K013625 | 000 |
| 10884523000023 | K013625 | 000 |
| 10884521196070 | K013625 | 000 |
| 10884521196063 | K013625 | 000 |
| 10884521190719 | K013625 | 000 |
| 10884523000016 | K013625 | 000 |
Trademark Results [PERMACOL]
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 |
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