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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 K953477
Device Name MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGING
Applicant
The DU Pont Co.
Medical Products
Bmp22/1170
Wilmington,  DE  19880
Applicant Contact JEAN E BARTLETT
Correspondent
The DU Pont Co.
Medical Products
Bmp22/1170
Wilmington,  DE  19880
Correspondent Contact JEAN E BARTLETT
Regulation Number892.2040
Classification Product Code
LMC  
Date Received07/24/1995
Decision Date 10/07/1995
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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