K954903 is an FDA 510(k) clearance for the PEDI VAGINAL ASPIRATOR. This device is classified as a Aspirator, Endocervical (Class II - Special Controls, product code HFC).
Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on April 29, 1996, 187 days after receiving the submission on October 25, 1995.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1050.
| 510(k) Number | K954903 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1995 |
| Decision Date | April 29, 1996 |
| Days to Decision | 187 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HFC — Aspirator, Endocervical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1050 |