The following data is part of a premarket notification filed by Axya Medical, Inc. with the FDA for Tufflex Polyester Suture.
| Device ID | K063194 |
| 510k Number | K063194 |
| Device Name: | TUFFLEX POLYESTER SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Contact | Howard L Schrayer |
| Correspondent | Howard L Schrayer AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-20 |
| Decision Date | 2006-12-04 |
| Summary: | summary |