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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K130410
Device Name DENTAL UNIT WITH CHAIR
Applicant
Xianyang North West Medical Instrument (Group) Co.
P.O. Box 237-023
Shanghai,  CN 200237
Applicant Contact Diana Hong
Correspondent
Xianyang North West Medical Instrument (Group) Co.
P.O. Box 237-023
Shanghai,  CN 200237
Correspondent Contact Diana Hong
Regulation Number872.6640
Classification Product Code
EIA  
Date Received02/19/2013
Decision Date 07/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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