The following data is part of a premarket notification filed by Marine Polymer Technologies, Inc. with the FDA for Mp 719.
Device ID | K111524 |
510k Number | K111524 |
Device Name: | MP 719 |
Classification | Wax, Bone |
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 | MTJ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-02 |
Decision Date | 2011-07-22 |
Summary: | summary |