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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 K041137
Device Name NEWTOM 3G QR-DVT 9000
Applicant
APERIO SERVICES, LLC
950 S. TAMIAMI TRAIL,
SUITE 102
SARASOTA,  FL  34236
Applicant Contact K. ROBERT WISNER
Correspondent
APERIO SERVICES, LLC
950 S. TAMIAMI TRAIL,
SUITE 102
SARASOTA,  FL  34236
Correspondent Contact K. ROBERT WISNER
Regulation Number892.1750
Classification Product Code
OAS  
Date Received04/30/2004
Decision Date 05/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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