FDA 510(k) Application Details - K081557

Device Classification Name Cassette, Radiographic Film

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510(K) Number K081557
Device Name Cassette, Radiographic Film
Applicant JDDB MANUFACTURING, INC
P.O. BOX 277782
RIVERDALE, IL 60827-7782 US
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Contact JACQUIN C YOUNGBLOOD-JOHNSON
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Regulation Number 892.1850

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Classification Product Code IXA
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Date Received 06/03/2008
Decision Date 09/10/2008
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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