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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K951948
Device Name KODAK XLS 8600 (PS)
Applicant
KODAK HEALTH IMAGING SYSTEMS, INC.
18325 WATERVIEW PKWY.
DALLAS,  TX  75252
Applicant Contact CARL ALLETTO
Correspondent
KODAK HEALTH IMAGING SYSTEMS, INC.
18325 WATERVIEW PKWY.
DALLAS,  TX  75252
Correspondent Contact CARL ALLETTO
Regulation Number892.2040
Classification Product Code
LMC  
Date Received04/26/1995
Decision Date 09/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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