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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K896984
Device Name PARI I.S.-2
Applicant
DURA PHARMACEUTICALS, INC.
P.O. BOX 2209
RAMONA,  CA  92065
Applicant Contact TOM EVANGELISTI
Correspondent
DURA PHARMACEUTICALS, INC.
P.O. BOX 2209
RAMONA,  CA  92065
Correspondent Contact TOM EVANGELISTI
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/11/1989
Decision Date 03/09/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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