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FDA 510(k) Application Details - K960998
Device Classification Name
Collimator, Automatic, Radiographic
More FDA Info for this Device
510(K) Number
K960998
Device Name
Collimator, Automatic, Radiographic
Applicant
XRE CORP.
300 FOSTER ST.
LITTLETON, MA 01460-2017 US
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Contact
WAYNE V LOOMER
Other 510(k) Applications for this Contact
Regulation Number
892.1610
More FDA Info for this Regulation Number
Classification Product Code
IZW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/12/1996
Decision Date
04/03/1996
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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