FDA 510(k) Application Details - K960981

Device Classification Name Device, Digital Image Storage, Radiological

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510(K) Number K960981
Device Name Device, Digital Image Storage, Radiological
Applicant KODAK HEALTH IMAGING SYSTEMS, INC.
18325 WATERVIEW PKWY.
DALLAS, TX 75252 US
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Contact STAN E TILLMAN
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Regulation Number 892.2010

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Classification Product Code LMB
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Date Received 03/11/1996
Decision Date 06/07/1996
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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