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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 K990384
Device Name EZFLOW CONTINUOUS NEBULIZER,MODEL 1005
Applicant
Piper Medical Products
4007 Seaport Blvd.
West Sacramento,  CA  95691
Applicant Contact SAMUEL DAVID PIPER, PE
Correspondent
Piper Medical Products
4007 Seaport Blvd.
West Sacramento,  CA  95691
Correspondent Contact SAMUEL DAVID PIPER, PE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/08/1999
Decision Date 04/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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