K944055 is an FDA 510(k) clearance for the FORCEPS, SURGICAL GYNECOLOGICAL, a Forceps, Surgical, Gynecological (Class II — Special Controls, product code HCZ), submitted by Owens Precision Systems, Inc. (Oak Creek, US). The FDA issued a Cleared decision on September 20, 1994, 32 days after receiving the submission on August 19, 1994. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K944055 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 19, 1994 |
| Decision Date | September 20, 1994 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HCZ — Forceps, Surgical, Gynecological |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |