The following data is part of a premarket notification filed by Marine Polymer Technologies with the FDA for Syvek Radial Band.
| Device ID | K132293 |
| 510k Number | K132293 |
| Device Name: | SYVEK RADIAL BAND |
| Classification | Clamp, Vascular |
| Applicant | MARINE POLYMER TECHNOLOGIES 107 WATER STREET Danvers, MA 01923 |
| Contact | Sergio Finkielsztein |
| Correspondent | Sergio Finkielsztein MARINE POLYMER TECHNOLOGIES 107 WATER STREET 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 | 2013-07-23 |
| Decision Date | 2014-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20389142000005 | K132293 | 000 |