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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
510(k) Number K894555
Device Name PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED
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 Number868.5640
Classification Product Code
CCQ  
Date Received07/20/1989
Decision Date 01/24/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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