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510(k) K920306

OPTI-MOL FILTERED PUNCTURE PIN by Automatic Liquid Packaging, Inc. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1992
Date Received
January 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

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  • K973829 — IRRIGATION BOTTLE (February 23, 1998)
  • K962079 — HUMIDIFIER ADAPTER (July 31, 1996)
  • K955104 — HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER (June 11, 1996)
  • 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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