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 |