The following data is part of a premarket notification filed by Winn Hirsch & Assoc. with the FDA for Type 316l Stainless Steel Wire.
| Device ID | K880309 |
| 510k Number | K880309 |
| Device Name: | TYPE 316L STAINLESS STEEL WIRE |
| Classification | Cerclage, Fixation |
| Applicant | WINN HIRSCH & ASSOC. 5256 N.W. 15TH ST. Margate, FL 33063 |
| Contact | Winn Hirsch |
| Correspondent | Winn Hirsch WINN HIRSCH & ASSOC. 5256 N.W. 15TH ST. Margate, FL 33063 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-25 |
| Decision Date | 1988-02-29 |