The following data is part of a premarket notification filed by Winn Hirsch & Assoc. with the FDA for Type 316l Cotter Wire.
| Device ID | K864375 |
| 510k Number | K864375 |
| Device Name: | TYPE 316L COTTER WIRE |
| Classification | Wire, Surgical |
| Applicant | WINN HIRSCH & ASSOC. 30 SYLVIA ROAD Plainview , NY 11803 - |
| Contact | Win Hirsch |
| Correspondent | Win Hirsch WINN HIRSCH & ASSOC. 30 SYLVIA ROAD Plainview , NY 11803 - |
| Product Code | LRN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-05 |
| Decision Date | 1987-05-20 |