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510(k) K904398

WATER COLUMN RELIEF VALVE by Icn Pharmaceuticals, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1991
Date Received
September 25, 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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  • K914530 — ICAN GT DRAINAGE BAG (December 18, 1991)
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  • K914086 — ICAN CYLINDRICAL SPONGES (October 9, 1991)
  • K914081 — ICAN COTTON RAYON BALLS (October 9, 1991)
  • K913446 — ICAN NEEDLE COUNTERS (September 13, 1991)
  • K770458 — BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. (May 10, 1977)
  • K770456 — PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT (May 3, 1977)

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