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510(k) K902516

NEW LENGTH SUGITA APPLIERS by Sims Surgical, Inc. — Product Code HIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1990
Date Received
June 7, 1990
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 by Sims Surgical, Inc.

  • K902180 — TRACHEAL TUBE STYLET (July 19, 1990)
  • K902517 — NEUROSURGICAL HEADFRAME ACCESSORIES (July 3, 1990)

Other clearances for product code HIC

  • K955790 — PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY (March 21, 1996)
  • K923656 — LIGHTING SOURCE SYSTEM (September 8, 1994)
  • K897100 — CENTURION VAGINAL SPECULUM (March 16, 1990)
  • K853257 — SPECULITE DISPOSABLE VAGINAL LIGHT (December 27, 1985)