K955790 is an FDA 510(k) clearance for the PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY. This device is classified as a Speculum, Vaginal, Nonmetal, Fiberoptic (Class II - Special Controls, product code HIC).
Submitted by Trylon Corp. (Monarch Beach, US). The FDA issued a Cleared decision on March 21, 1996, 90 days after receiving the submission on December 22, 1995.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K955790 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1995 |
| Decision Date | March 21, 1996 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HIC — Speculum, Vaginal, Nonmetal, Fiberoptic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |