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 |