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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 K093485
Device Name VESISCAN
Applicant
Life-Tech, Inc.
13235 N Promenade Blvd.
Stafford,  TX  77477
Applicant Contact JEFF KASOFF
Correspondent
Life-Tech, Inc.
13235 N Promenade Blvd.
Stafford,  TX  77477
Correspondent Contact JEFF KASOFF
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/09/2009
Decision Date 03/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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