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FDA 510(k) Application Details - K961849
Device Classification Name
System, X-Ray, Mammographic
More FDA Info for this Device
510(K) Number
K961849
Device Name
System, X-Ray, Mammographic
Applicant
SHAI SYG MOTION AND INNOVATIONS, LTD.
POB 6718
EFRAT 90435 IL
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Contact
ELI M ORBACH
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Regulation Number
892.1710
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Classification Product Code
IZH
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More FDA Info for this Product Code
Date Received
05/13/1996
Decision Date
08/21/1996
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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