K914552 is an FDA 510(k) clearance for the CMI VACUUM PUMP. This device is classified as a Forceps, Obstetrical (Class II — Special Controls, product code HDA).
Submitted by Columbia Medical & Surgical, Inc. (Bend, US). The FDA issued a Cleared decision on September 7, 1993, 697 days after receiving the submission on October 11, 1991.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4400.
| 510(k) Number | K914552 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 11, 1991 |
| Decision Date | September 07, 1993 |
| Days to Decision | 697 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HDA — Forceps, Obstetrical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4400 |