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FDA 510(k) Application Details - K122510
Device Classification Name
Full Field Digital,System,X-Ray,Mammographic
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510(K) Number
K122510
Device Name
Full Field Digital,System,X-Ray,Mammographic
Applicant
ICRCO INC.
2580 WEST 237TH STREET
TORRANCE, CA 90505 US
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Contact
GREG WACHTLER
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Regulation Number
000.0000
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Classification Product Code
MUE
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More FDA Info for this Product Code
Date Received
08/17/2012
Decision Date
04/26/2013
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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