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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Densitometer, Bone
510(k) Number K003656
Device Name X-POSURE SYSTEM VERSION 2 MAMMO
Applicant
PRONOSCO A/S
555 13TH ST.
WASHINGTON,  DC  20004
Applicant Contact JONATHAN S KAHN
Correspondent
PRONOSCO A/S
555 13TH ST.
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN S KAHN
Regulation Number892.1170
Classification Product Code
KGI  
Date Received11/27/2000
Decision Date 12/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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