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510(k) K830725

GENT-L-SPEC DISPOS. VAGINAL SPECULUM by Geneva Laboratories, Inc. — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1983
Date Received
March 8, 1983
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 Geneva Laboratories, Inc.

  • K881217 — GENT-L-KARE STERILE URINARY LEG BAG (July 29, 1988)
  • K881218 — GENT-L-KARE CLEANSING ENEMA SET (July 28, 1988)
  • K881213 — GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER (July 28, 1988)
  • K881216 — GENT-L-KARE VAGINAL IRRIGATION SET (June 7, 1988)
  • K861308 — ACCUPAC CUSTOM PACK KERLIX SQUARES (May 2, 1986)
  • K861219 — ACCUPAC CUSTOM SKIN SCRUB KIT (April 15, 1986)
  • K853265 — ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543 (August 26, 1985)
  • K843206 — COOK COUNTY HOSPITAL DRESSING CHANGE SET (May 24, 1985)
  • K844255 — GENT-L-KARE STERILE I.V. START KIT (December 19, 1984)
  • K843090 — UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM (December 4, 1984)

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  • K072942 — MEDLINE DISPOSABLE VAGINAL SPECULUM (February 8, 2008)
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