The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Braided Polyester Suture Material.
| Device ID | K923161 |
| 510k Number | K923161 |
| Device Name: | BRAIDED POLYESTER SUTURE MATERIAL |
| Classification | Suture, Nonabsorbable, Synthetic, Polyester |
| Applicant | MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood, MA 02062 |
| Contact | Robert P Zoletti |
| Correspondent | Robert P Zoletti MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood, MA 02062 |
| Product Code | GAS |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-29 |
| Decision Date | 1992-12-30 |