The following data is part of a premarket notification filed by Owens Precision Systems, Inc. with the FDA for Owens Biopsy Forceps.
| Device ID | K924224 |
| 510k Number | K924224 |
| Device Name: | OWENS BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Gynecological |
| Applicant | OWENS PRECISION SYSTEMS, INC. 7815 SOUTH 6TH ST. Oak Creek, WI 53154 |
| Contact | Lanis Pfolsgrof |
| Correspondent | Lanis Pfolsgrof OWENS PRECISION SYSTEMS, INC. 7815 SOUTH 6TH ST. Oak Creek, WI 53154 |
| Product Code | HFB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-21 |
| Decision Date | 1994-02-04 |