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FDA 510(k) Application Details - K961768
Device Classification Name
Digitizer, Image, Radiological
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510(K) Number
K961768
Device Name
Digitizer, Image, Radiological
Applicant
KODAK HEALTH IMAGING SYSTEMS, INC.
18325 WATERVIEW PKWY.
DALLAS, TX 75252 US
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Contact
EDWARD A WEAVER
Other 510(k) Applications for this Contact
Regulation Number
892.2030
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Classification Product Code
LMA
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More FDA Info for this Product Code
Date Received
05/08/1996
Decision Date
08/22/1996
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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