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510(k) K922880

XOMED TREACE JET VENTILATION TUBE by Xomed-Treace, Inc. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1993
Date Received
June 15, 1992
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 Xomed-Treace, Inc.

  • K940028 — ENDOSCOPE SHEATH (March 24, 1995)
  • 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)
  • K923830 — XOMED-TREACE ALPHASCOPE (November 9, 1992)
  • K912753 — XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL (September 23, 1991)

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