FDA 510(k) Application Details - K040378

Device Classification Name Cassette, Radiographic Film

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510(K) Number K040378
Device Name Cassette, Radiographic Film
Applicant EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER, NY 14650-1131 US
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Contact SUSAN PATE
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Regulation Number 892.1850

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Classification Product Code IXA
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Date Received 02/17/2004
Decision Date 05/24/2004
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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