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510(k) K955790

PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY by Trylon Corp. — Product Code HIC

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

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Other clearances for product code HIC

  • K923656 — LIGHTING SOURCE SYSTEM (September 8, 1994)
  • K902516 — NEW LENGTH SUGITA APPLIERS (July 3, 1990)
  • K897100 — CENTURION VAGINAL SPECULUM (March 16, 1990)
  • K853257 — SPECULITE DISPOSABLE VAGINAL LIGHT (December 27, 1985)