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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K923042
Device Name DU PONT LINX HD-25 LASR IMAGER
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Du Pont-Bmp22/1152
Wilmington,  DE  19880
Applicant Contact RICHARD M FORBIS
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Du Pont-Bmp22/1152
Wilmington,  DE  19880
Correspondent Contact RICHARD M FORBIS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/24/1992
Decision Date 11/09/1992
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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