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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K090526
Device Name MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR
Applicant
E-Woo Technology
256 N. Sam Houston Pkwy. E.
Suite 115
Houston,  TX  77060
Applicant Contact VINCENT LEE
Correspondent
E-Woo Technology
256 N. Sam Houston Pkwy. E.
Suite 115
Houston,  TX  77060
Correspondent Contact VINCENT LEE
Regulation Number872.1800
Classification Product Code
MUH  
Date Received02/26/2009
Decision Date 12/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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