The following data is part of a premarket notification filed by Axya Medical, Inc. with the FDA for Suture Welding System And Kit (swk).
| Device ID | K983108 |
| 510k Number | K983108 |
| Device Name: | SUTURE WELDING SYSTEM AND KIT (SWK) |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| 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 | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-04 |
| Decision Date | 1998-11-27 |
| Summary: | summary |