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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 K111227
Device Name ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
ALOKA CO., LTD.
10 FAIRFIELD BLVD.
WALLINGFORD,  CT  06492 -7502
Applicant Contact YUKITOSHI KIYOMURA
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact MICHAEL S OGUNLEYE
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received05/02/2011
Decision Date 05/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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