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510(k) K871692

TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1 by Automatic Liquid Packaging, Inc. — Product Code LRQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1987
Date Received
April 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tracheostomy And Nasal Suctioning Kit
Device Class
Class I
Regulation Number
Review Panel
SU
Submission Type

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Automatic Liquid Packaging, Inc.

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  • 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 LRQ

  • K963720 — TRACHEOSTOMY KIT (November 27, 1996)
  • K961167 — MEDCARE TRACHEOSTOMY CARE TRAY (July 2, 1996)
  • K952925 — READY NURSE SYSTEM (RNS) TRACH CARE KIT (July 12, 1995)
  • K950851 — GENT-L-KARE TRACHEOSTOMY TRAYS (June 21, 1995)
  • K862663 — TRACHEOSTOMY CARE TRAY (July 30, 1986)