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510(k) K901079

SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER by L H M Ent., Inc. — Product Code BTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1990
Date Received
March 7, 1990
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 L H M Ent., Inc.

  • K901078 — SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE (May 18, 1990)
  • K894610 — CUSTOM TRAYS, KITS (March 15, 1990)
  • K900439 — SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC (February 15, 1990)
  • K894611 — CATHETER CARE KITS (December 15, 1989)
  • K883506 — IRRIGATION KIT (December 13, 1988)

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)