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510(k) K871632

NASOGASTRIC VOICETUBE by American Omni Medical, Inc. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1987
Date Received
April 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
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)
  • K873488 — SILENT GUARD CAT. NO. SG-10 (October 7, 1987)

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