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FDA 510(k) Application Details - K962338
Device Classification Name
Grid, Radiographic
More FDA Info for this Device
510(K) Number
K962338
Device Name
Grid, Radiographic
Applicant
UNIDEX GROUP, INC.
2400 EAST DEVON AVE.
DES PLAINES, IL 60018 US
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Contact
HENRY LEE
Other 510(k) Applications for this Contact
Regulation Number
892.1910
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Classification Product Code
IXJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/17/1996
Decision Date
07/03/1996
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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