The following data is part of a premarket notification filed by Promethean Surgical Devices, Inc. with the FDA for Hydrocoat Mesh.
| Device ID | K090271 |
| 510k Number | K090271 |
| Device Name: | HYDROCOAT MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | PROMETHEAN SURGICAL DEVICES, INC. 111 ROBERTS ST., SUITE G2 East Hartford, CT 06108 |
| Contact | Kenneth K Kleinhenz |
| Correspondent | Kenneth K Kleinhenz PROMETHEAN SURGICAL DEVICES, INC. 111 ROBERTS ST., SUITE G2 East Hartford, CT 06108 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-04 |
| Decision Date | 2010-01-14 |
| Summary: | summary |