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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 K003787
Device Name NEWTOM QR-DVT 9000
Applicant
APERIO SERVICES, LLC
815 CONNECTICUT AVENUE, NW
WASHINGTON,,  DC  20006 -4078
Applicant Contact GREGORY W BOWMAN
Correspondent
APERIO SERVICES, LLC
815 CONNECTICUT AVENUE, NW
WASHINGTON,,  DC  20006 -4078
Correspondent Contact GREGORY W BOWMAN
Regulation Number892.1750
Classification Product Code
OAS  
Date Received12/08/2000
Decision Date 03/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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