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510(k) K955104

HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER by Automatic Liquid Packaging, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1996
Date Received
November 8, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

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  • K973829 — IRRIGATION BOTTLE (February 23, 1998)
  • K962079 — HUMIDIFIER ADAPTER (July 31, 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)
  • K901301 — STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL (May 31, 1990)

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