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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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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