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510(k) K941641

DISPOSABLE EMERGENCY OBSTETRICAL KIT by Gam Industries, Inc. — Product Code KNA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1994
Date Received
April 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Gam Industries, Inc.

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  • K942021 — MOUTH TO MOUTH BREATHER (June 22, 1994)
  • K936050 — JAW SPREADER (March 24, 1994)
  • K930401 — ALUMINUM FOIL (May 12, 1993)
  • K926290 — BURN SHEET (April 20, 1993)
  • K925590 — MULTI-TRAUMA DRESSING (April 8, 1993)
  • K915569 — UMBILICAL CLAMP (September 23, 1992)
  • K915303 — FOIL BABY BUNTING (February 20, 1992)

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  • K001590 — DND 101 (August 2, 2000)
  • K990738 — DR. JAHANGER'S CUTTER (October 29, 1999)