The following data is part of a premarket notification filed by Marine Polymer Technologies, Inc. with the FDA for Talymed Suspension.
| Device ID | K160695 |
| 510k Number | K160695 |
| Device Name: | Talymed Suspension |
| Classification | Dressing, Wound, Drug |
| Applicant | Marine Polymer Technologies, Inc. 107 Water Street Danvers, MA 01923 |
| Contact | Sergio Finkielsztein |
| Correspondent | Sergio Finkielsztein Marine Polymer Technologies, Inc. 107 Water Street Danvers, MA 01923 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-03-14 |
| Decision Date | 2016-12-06 |
| Summary: | summary |