The following data is part of a premarket notification filed by Marine Polymer Technologies, Inc. with the FDA for Mp 719.
Device ID | K070557 |
510k Number | K070557 |
Device Name: | MP 719 |
Classification | Dressing, Wound, Drug |
Applicant | MARINE POLYMER TECHNOLOGIES, INC. 461 BOSTON ST., UNIT B5 Topsfield, MA 01983 |
Contact | Sergio Finkielsztein |
Correspondent | Sergio Finkielsztein MARINE POLYMER TECHNOLOGIES, INC. 461 BOSTON ST., UNIT B5 Topsfield, MA 01983 |
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 | 2007-02-27 |
Decision Date | 2007-05-23 |
Summary: | summary |