FDA 510(k) Application Details - K052433

Device Classification Name Cabinet,X-Ray System

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510(K) Number K052433
Device Name Cabinet,X-Ray System
Applicant BIOPTICS, INC.
3496 S. DODGE BLVD., SUITE 110
TUCSON, AZ 85713 US
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Contact JEFFREY ORACH
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Regulation Number 892.1680

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Classification Product Code MWP
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Date Received 09/06/2005
Decision Date 10/18/2005
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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