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510(k) K923656

LIGHTING SOURCE SYSTEM by Galenica Enterprises, Inc. — Product Code HIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1994
Date Received
July 13, 1992
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 Galenica Enterprises, Inc.

  • K896383 — DISPOSABLE EXTERNAL CLAMPS (December 6, 1989)
  • K883283 — DISPOSABLE AMNIOTOME (October 18, 1988)
  • K861017 — GALENICA'S DISPOSABLE ANOSCOPES (June 13, 1986)
  • K841909 — VAGINAL SPECULUM - DISPOSABLE (July 31, 1984)

Other clearances for product code HIC

  • K955790 — PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY (March 21, 1996)
  • K902516 — NEW LENGTH SUGITA APPLIERS (July 3, 1990)
  • K897100 — CENTURION VAGINAL SPECULUM (March 16, 1990)
  • K853257 — SPECULITE DISPOSABLE VAGINAL LIGHT (December 27, 1985)