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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, mammographic
510(k) Number K050663
Device Name TRAXYLOC-1 SYSTEM
Applicant
TRAXYZ MEDICAL, INC.
290 TURNPIKE RD SUITE 6 #323
WESTBORO,  MA  01581
Applicant Contact F. DAVID ROTHKOPF
Correspondent
TRAXYZ MEDICAL, INC.
290 TURNPIKE RD SUITE 6 #323
WESTBORO,  MA  01581
Correspondent Contact F. DAVID ROTHKOPF
Regulation Number892.1710
Classification Product Code
IZH  
Date Received03/15/2005
Decision Date 04/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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