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510(k) K841909

VAGINAL SPECULUM - DISPOSABLE by Galenica Enterprises, Inc. — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1984
Date Received
May 9, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Vaginal, Nonmetal
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Galenica Enterprises, Inc.

  • K923656 — LIGHTING SOURCE SYSTEM (September 8, 1994)
  • K896383 — DISPOSABLE EXTERNAL CLAMPS (December 6, 1989)
  • K883283 — DISPOSABLE AMNIOTOME (October 18, 1988)
  • K861017 — GALENICA'S DISPOSABLE ANOSCOPES (June 13, 1986)

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  • K133857 — BRELLA-SPEC(TM) VAGINAL SPECULUM (April 28, 2014)
  • K132668 — IOB DISPOSABLE SPECULUM (January 17, 2014)
  • K130046 — CLEARSPEC SINGLE USE VAGINAL SPECULUM (August 6, 2013)
  • K120743 — SPECULUM, VAGINAL, NONMETAL (March 23, 2012)
  • K110766 — KOLPLUX SYSTEM (September 15, 2011)
  • K092870 — NON-STERILE DISPOSABLE VAGINAL SPECULUM (February 16, 2010)
  • K091937 — OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM (September 9, 2009)
  • K072942 — MEDLINE DISPOSABLE VAGINAL SPECULUM (February 8, 2008)
  • K072762 — DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM (January 22, 2008)