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510(k) K831511

TRACHEOSTOMY TUBE by Implant Technology, Inc. — Product Code BTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1983
Date Received
May 12, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheostomy (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

Other clearances by Implant Technology, Inc.

  • K921525 — HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS (January 11, 1995)
  • K915617 — LSF HA COATED FEMORAL HIP (May 28, 1992)
  • K920021 — LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP (March 25, 1992)
  • K913616 — LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP (November 7, 1991)
  • K902727 — LSF CEMENTED FEMORAL HIP (August 9, 1990)
  • K901460 — LSF(TM) TOTAL HIP SYSTEM (May 22, 1990)
  • K891472 — IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR (May 2, 1989)
  • K884432 — MODIFIED LSF TOTAL HIP SYSTEM (December 9, 1988)
  • K883212 — LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT (November 22, 1988)
  • K855017 — LSF* TOTAL HIP SYSTEM (June 11, 1986)

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  • K173384 — BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestr (April 10, 2018)
  • K120079 — PRIMED TRACHEOSTOMY TUBES (MULTIPLE) (May 24, 2012)
  • K101721 — WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (March 24, 2011)
  • K100950 — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE (July 13, 2010)
  • K100480 — ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH (June 11, 2010)
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  • K083031 — PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT (August 18, 2009)