FDA 510(k) Application Details - K073262

Device Classification Name System, X-Ray, Mammographic

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510(K) Number K073262
Device Name System, X-Ray, Mammographic
Applicant BEEKLEY CORP.
150 DOLPHIN RD.
BRISTOL, CT 06011 US
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Contact MARTINE M BOUTTE
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Regulation Number 892.1710

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Classification Product Code IZH
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Date Received 11/20/2007
Decision Date 03/26/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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