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510(k) K880317

PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP by Automatic Liquid Packaging, Inc. — Product Code BTO

K880317 is an FDA 510(k) premarket notification submitted by Automatic Liquid Packaging, Inc. for the device "PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP". The FDA issued a decision of Substantially Equivalent on February 29, 1988. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Automatic Liquid Packaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 1988
Date Received
January 26, 1988
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 Automatic Liquid Packaging, Inc.

  • K994321 — STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (October 25, 2000)
  • K000964 — STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109 (April 25, 2000)
  • K980147 — YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION (April 13, 1998)
  • K973829 — IRRIGATION BOTTLE (February 23, 1998)
  • K962079 — HUMIDIFIER ADAPTER (July 31, 1996)
  • K955104 — HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER (June 11, 1996)
  • K920306 — OPTI-MOL FILTERED PUNCTURE PIN (April 6, 1992)
  • K911770 — OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM (October 15, 1991)
  • K901762 — PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM (July 17, 1990)
  • K901362 — ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE (June 6, 1990)

Other clearances for product code BTO

  • K242921 — 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes (June 10, 2025)
  • 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)

FDA data resources