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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 K042095
Device Name MAMMOTEST
Applicant
FISCHER IMAGING CORP.
12300 NORTH GRANT ST.
DENVER,  CO  80241 -3120
Applicant Contact ROBERT G SCHUEPPERT
Correspondent
FISCHER IMAGING CORP.
12300 NORTH GRANT ST.
DENVER,  CO  80241 -3120
Correspondent Contact ROBERT G SCHUEPPERT
Regulation Number892.1710
Classification Product Code
IZH  
Subsequent Product Code
JAQ  
Date Received08/03/2004
Decision Date 10/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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