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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 Doppler, Ultrasonic
510(k) Number K090229
Device Name DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV
Applicant
Chang Gung Medical Supplies & Equipment Corp.
7263 Cronin Cir.
Dublin,  CA  94568
Applicant Contact BOB LEIKER
Correspondent
Chang Gung Medical Supplies & Equipment Corp.
7263 Cronin Cir.
Dublin,  CA  94568
Correspondent Contact BOB LEIKER
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received01/30/2009
Decision Date 03/13/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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