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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 K033833
Device Name EFLOW ELECTRONIC INHALER/NEBULIZER
Applicant
Pari Innovative Manufacturers, Inc.
2943 Oak Lake Blvd.
Midlothian,  VA  23112
Applicant Contact LAWRENCE WEINSTEIN
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/10/2003
Decision Date 05/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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