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510(k) K901362

ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE by Automatic Liquid Packaging, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1990
Date Received
March 23, 1990
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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  • K911770 — OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM (October 15, 1991)
  • K901762 — PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM (July 17, 1990)
  • K901301 — STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL (May 31, 1990)

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