The following data is part of a premarket notification filed by Retrax with the FDA for Magnetic Point Guard For Surgical Needles.
| Device ID | K920706 |
| 510k Number | K920706 |
| Device Name: | MAGNETIC POINT GUARD FOR SURGICAL NEEDLES |
| Classification | Holder, Needle, Gastroenterologic |
| Applicant | RETRAX 800 W. WAUSAU CIRCLE WAUSAU, WI 54401 |
| Contact | DONALD KRANENDOBK |
| Correspondent | DONALD KRANENDOBK RETRAX 800 W. WAUSAU CIRCLE WAUSAU, WI 54401 |
| Product Code | FHQ |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-18 |
| Decision Date | 1993-05-26 |