FDA 510(k) Application Details - K020624

Device Classification Name System, X-Ray, Mammographic

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510(K) Number K020624
Device Name System, X-Ray, Mammographic
Applicant BEEKLEY CORP.
PRESTIGE LN.
BRISTOL, CT 06010 US
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Contact MAEGHAN E ARCHAMBAULT
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Regulation Number 892.1710

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Classification Product Code IZH
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Date Received 02/26/2002
Decision Date 09/12/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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