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FDA 510(k) Application Details - K993740
Device Classification Name
System, X-Ray, Mammographic
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510(K) Number
K993740
Device Name
System, X-Ray, Mammographic
Applicant
MEDICAL SYSTEMS GROUP
11550 WEST KING ST.
FRANKLIN PARK, IL 60131 US
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Contact
JEFFREY N MOELLER
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Regulation Number
892.1710
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Classification Product Code
IZH
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More FDA Info for this Product Code
Date Received
11/04/1999
Decision Date
11/26/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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