FDA 510(k) Application Details - K962336

Device Classification Name Cassette, Radiographic Film

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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

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Classification Product Code IXA
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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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