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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 Tpke. Rd.
Suite 6 #323
Westborough,  MA  01581
Applicant Contact F. DAVID ROTHKOPF
Correspondent
Traxyz Medical, Inc.
290 Tpke. Rd.
Suite 6 #323
Westborough,  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
Predetermined Change
Control Plan Authorized		 No
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