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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 K040718
Device Name TRUST
Applicant
Dhd Healthcare Corp.
One Madison St.
Wampsville,  NY  13163
Applicant Contact DAVID GEARY
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/19/2004
Decision Date 04/02/2004
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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