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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K090171
Device Name COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D
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 Number892.1750
Classification Product Code
OAS  
Date Received01/23/2009
Decision Date 04/30/2009
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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