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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K072210
Device Name CHISON, MODEL 8300
Applicant
Chison Medical Imaging Co., Ltd.
Suite 8 Zhongshan Mansion, Lane
999, Zhongshan #02 Rd. (S)
Shanghai,  CN 200030
Applicant Contact Diana Hong
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received08/09/2007
Decision Date 08/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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