The following data is part of a premarket notification filed by Owens Precision Systems, Inc. with the FDA for Forceps, Surgical Gynecological.
| Device ID | K944055 |
| 510k Number | K944055 |
| Device Name: | FORCEPS, SURGICAL GYNECOLOGICAL |
| Classification | Forceps, Surgical, Gynecological |
| Applicant | OWENS PRECISION SYSTEMS, INC. 7815 SOUTH 6TH ST. Oak Creek, WI 53154 |
| Contact | Lanis P Pfolsgrof |
| Correspondent | Lanis P Pfolsgrof OWENS PRECISION SYSTEMS, INC. 7815 SOUTH 6TH ST. Oak Creek, WI 53154 |
| Product Code | HCZ |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-19 |
| Decision Date | 1994-09-20 |