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510(k) K912753

XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL by Xomed-Treace, Inc. — Product Code GCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1991
Date Received
June 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Xomed-Treace, Inc.

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  • K941407 — TYMPANOSTOMY (VENTILATION) TUBE (March 14, 1995)
  • K945659 — BLACKSTAR(TM) STAR SYSTEM (January 9, 1995)
  • K932771 — BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (August 24, 1994)
  • K933672 — XOMED-TREACE SCOPESHEATH (July 18, 1994)
  • K934426 — NERVE INTEGRITY MONITOR-2 (NIM-2 XL) (May 13, 1994)
  • K933105 — XOMED-TREACE RIGID ROD LENS ENDOSCOPE (January 5, 1994)
  • K925640 — XOMED-TREACE EMG ENDOTRACHEAL TUBEEN (August 17, 1993)
  • K922880 — XOMED TREACE JET VENTILATION TUBE (April 15, 1993)
  • K923830 — XOMED-TREACE ALPHASCOPE (November 9, 1992)

Other clearances for product code GCX

  • K042454 — STRYKER CASSETTE PUMP (December 9, 2004)
  • K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (August 3, 1999)
  • K972074 — SUCTION INSTRUMENTATION (July 25, 1997)
  • K971022 — CHASE SUCKER (April 17, 1997)
  • K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (December 31, 1996)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)
  • K963648 — STRYKER SUCTION REGULATOR (November 26, 1996)
  • K962920 — RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (October 21, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K960223 — CPR YANKAUER (March 28, 1996)