The following data is part of a premarket notification filed by Marine Polymer Technologies, Inc. with the FDA for Syvek Patch.
| Device ID | K972914 |
| 510k Number | K972914 |
| Device Name: | SYVEK PATCH |
| Classification | Tape And Bandage, Adhesive |
| Applicant | MARINE POLYMER TECHNOLOGIES, INC. 107 WATER ST. Danvers, MA 01923 |
| Contact | Sergio Finkielsztein |
| Correspondent | Sergio Finkielsztein MARINE POLYMER TECHNOLOGIES, INC. 107 WATER ST. Danvers, MA 01923 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-07 |
| Decision Date | 1997-12-22 |