The following data is part of a premarket notification filed by Axya Medical, Inc. with the FDA for Axya Suture Welding System And Kit.
| Device ID | K070253 |
| 510k Number | K070253 |
| Device Name: | AXYA SUTURE WELDING SYSTEM AND KIT |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Contact | Howard Schrayer |
| Correspondent | Howard 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-26 |
| Decision Date | 2007-07-11 |
| Summary: | summary |