The following data is part of a premarket notification filed by Trylon Corp. with the FDA for Pap Plus Speculoscopy Comprehensive Pelvic Exam Tray.
| Device ID | K955790 |
| 510k Number | K955790 |
| Device Name: | PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY |
| Classification | Speculum, Vaginal, Nonmetal, Fiberoptic |
| Applicant | TRYLON CORP. 23268 ATLANTIS WAY Monarch Beach, CA 92629 |
| Contact | A. Thomas Doyle |
| Correspondent | A. Thomas Doyle TRYLON CORP. 23268 ATLANTIS WAY Monarch Beach, CA 92629 |
| Product Code | HIC |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-22 |
| Decision Date | 1996-03-21 |