FDA 510(k) Application Details - K961740

Device Classification Name System, Image Processing, Radiological

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510(K) Number K961740
Device Name System, Image Processing, Radiological
Applicant KODAK HEALTH IMAGING SYSTEMS, INC.
18325 WATERVIEW PKWY.
DALLAS, TX 75252 US
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Contact NANCY BUTCHER
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 05/03/1996
Decision Date 11/14/1996
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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