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 |