The following data is part of a premarket notification filed by Marine Polymer Technologies, Inc. with the FDA for Syvekexcel.
Device ID | K053300 |
510k Number | K053300 |
Device Name: | SYVEKEXCEL |
Classification | Clamp, Vascular |
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 | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-11-25 |
Decision Date | 2006-03-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00389142000155 | K053300 | 000 |
10389142000053 | K053300 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SYVEKEXCEL 85565288 4362156 Live/Registered |
MARINE POLYMER TECHNOLOGIES, INC. 2012-03-09 |