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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 K062689
Device Name SIDESTREAM PLUS
Applicant
Respironics , Ltd.
41 Canfield Rd.
Cedar Grove,  NJ  07009
Applicant Contact Lauren Ziegler
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/11/2006
Decision Date 02/16/2007
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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