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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Film Marking, Radiographic
510(k) Number K910354
Device Name DU PONT IDENTIFICATION CAMERA
Applicant
Dupont Medical Products
Diagnostics & Biotechnology
Systems Division
Wilmington,  DE  19880
Applicant Contact RICHARD M VAUGHT
Correspondent
Dupont Medical Products
Diagnostics & Biotechnology
Systems Division
Wilmington,  DE  19880
Correspondent Contact RICHARD M VAUGHT
Regulation Number892.1640
Classification Product Code
JAC  
Date Received01/29/1991
Decision Date 03/29/1991
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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