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FDA 510(k) Application Details - K962336
Device Classification Name
Cassette, Radiographic Film
More FDA Info for this Device
510(K) Number
K962336
Device Name
Cassette, Radiographic Film
Applicant
UNIDEX GROUP, INC.
2400 EAST DEVON AVE.,
SUITE 205
DES PLAINES, IL 60018 US
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Contact
HENRY LEE
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Regulation Number
892.1850
More FDA Info for this Regulation Number
Classification Product Code
IXA
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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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