The following data is part of a premarket notification filed by Marine Polymer Technologies with the FDA for Talymed.
| Device ID | K102002 |
| 510k Number | K102002 |
| Device Name: | TALYMED |
| Classification | Dressing, Wound, Drug |
| Applicant | MARINE POLYMER TECHNOLOGIES 107 WATER STREET Danvers, MA 01983 |
| Contact | Sergio Finkielsztein |
| Correspondent | Sergio Finkielsztein MARINE POLYMER TECHNOLOGIES 107 WATER STREET Danvers, MA 01983 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-15 |
| Decision Date | 2010-07-28 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TALYMED 85083312 4139696 Live/Registered |
MARINE POLYMER TECHNOLOGIES, INC. 2010-07-13 |