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510(k) K873488

SILENT GUARD CAT. NO. SG-10 by American Omni Medical, Inc. — Product Code DTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1987
Date Received
August 31, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4290
Review Panel
CV
Submission Type

Other clearances by American Omni Medical, Inc.

  • K922781 — FLOW CONROL VALVE (March 8, 1993)
  • K922356 — FLOW CONTROL VALVE, CAT. NO. ACV-38 (February 12, 1993)
  • K900672 — PREBYPASS FILTER, CAT. NO. FPB-5 (April 3, 1990)
  • K884893 — CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 (January 30, 1989)
  • K884640 — CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 (January 24, 1989)
  • K873316 — BUBBLE TRAP-FILTER CAT. NO B180F37 (July 14, 1988)
  • K875080 — AIR VENT LINE CAT. NO. AVL-36 (February 29, 1988)
  • K873802 — PRESSURE BARRIER KIT CAT. NO. PBK-3 (November 6, 1987)
  • K873610 — PEDIATRIC BUBBLE TRAP CAT. NO. B-100 (November 5, 1987)
  • K871632 — NASOGASTRIC VOICETUBE (September 16, 1987)

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  • K122811 — CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE (October 12, 2012)
  • K122301 — GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE (September 7, 2012)
  • K120069 — MEDLINE STOPCOCK AND MANIFOLD (April 3, 2012)
  • K113148 — E-PASS (February 28, 2012)
  • K113845 — TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE (January 25, 2012)