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510(k) K761190

TRACHEOSTOMY CARE KIT by Superior Plastic Products Corp. — Product Code BTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1976
Date Received
December 6, 1976
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 Superior Plastic Products Corp.

  • K851981 — NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC. (June 18, 1985)
  • K843975 — 9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE (November 20, 1984)
  • K841945 — ENTERAL FEEDING BOTTLE (July 26, 1984)
  • K841630 — ENTERAL NUTRITION PUMP (June 7, 1984)
  • K840324 — SILICONE SUMP DRAIN 20 & 40 FRENCH (April 25, 1984)
  • K840323 — SILICONE SUCTION & IRRIGATION DRAIN (April 25, 1984)
  • K841480 — INFECTION CONTROL VALVE (April 25, 1984)
  • K833687 — DISPOS. ENTERIC FEEDING TUBES W/SAFE-T (March 2, 1984)
  • K833947 — SUPERIOR ENTERNAL FEEDING SYSTEM (February 4, 1984)
  • K820460 — 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION (March 8, 1982)

Other clearances for product code BTO

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  • K233713 — Pilling Tracheostomy Tubes (March 22, 2024)
  • K192511 — Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy (July 22, 2020)
  • 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)
  • K100283 — VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PRE (April 23, 2010)
  • K083031 — PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT (August 18, 2009)