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510(k) K896984

PARI I.S.-2 by Dura Pharmaceuticals, Inc. — Product Code CAF

Clearance Details

Decision
SN ()
Decision Date
March 9, 1990
Date Received
December 11, 1989
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

Other clearances by Dura Pharmaceuticals, Inc.

  • K936110 — ASPIRE (March 23, 1995)
  • K894555 — PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED (January 24, 1990)

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