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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 K062952
Device Name C300 SERIES AIR NEBULIZER COMPRESSOR
Applicant
Choice Smart Health Care Co. , Ltd.
2108 Ciro'S Plaza
388 W. Nanjing Rd.
Shanghai,  CN 200003
Applicant Contact JANICE MA
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MICHELLE S LEE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/29/2006
Decision Date 02/21/2007
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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