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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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More FDA Info for this Product Code
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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