Home / 510(k) Clearances / K853257

510(k) K853257

SPECULITE DISPOSABLE VAGINAL LIGHT by Trylon Associates, Ltd. — Product Code HIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1985
Date Received
August 2, 1985
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

Other clearances for product code HIC

  • K955790 — PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY (March 21, 1996)
  • K923656 — LIGHTING SOURCE SYSTEM (September 8, 1994)
  • K902516 — NEW LENGTH SUGITA APPLIERS (July 3, 1990)
  • K897100 — CENTURION VAGINAL SPECULUM (March 16, 1990)