The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Passing Pins And Surgical Wire.
| Device ID | K920621 |
| 510k Number | K920621 |
| Device Name: | ACUFEX PASSING PINS AND SURGICAL WIRE |
| Classification | Passer |
| Applicant | ACUFEX MICROSURGICAL, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Ivan S Placko |
| Correspondent | Ivan S Placko ACUFEX MICROSURGICAL, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | HWQ |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-11 |
| Decision Date | 1993-05-05 |