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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cabinet, x-ray system
510(k) Number K021113
Device Name MAMMOPATH
Applicant
FISCHER IMAGING CORP.
12300 NORTH GRANT ST.
DENVER,  CO  80241 -3120
Applicant Contact SAMIR B PALIWAL
Correspondent
FISCHER IMAGING CORP.
12300 NORTH GRANT ST.
DENVER,  CO  80241 -3120
Correspondent Contact SAMIR B PALIWAL
Regulation Number892.1680
Classification Product Code
MWP  
Date Received04/05/2002
Decision Date 06/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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