510(k) K955790
K955790 is an FDA 510(k) premarket notification submitted by Trylon Corp. for the device "PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY". The FDA issued a decision of Substantially Equivalent on March 21, 1996. The device falls under product code HIC (Speculum, Vaginal, Nonmetal, Fiberoptic), a Class II device regulated under 21 CFR 884.4530. Trylon Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 1996
- Date Received
- December 22, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Speculum, Vaginal, Nonmetal, Fiberoptic
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type