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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clinical Sample Concentrator
510(k) Number K851393
Device Name DUPONT PREP FOUR-SOLVENT RETROFIT KIT
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Department
Barley Mill Plaza, P22-1170
Wilmington,  DE  19898
Applicant Contact RICHARD M YAUGHT
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Department
Barley Mill Plaza, P22-1170
Wilmington,  DE  19898
Correspondent Contact RICHARD M YAUGHT
Regulation Number862.2310
Classification Product Code
JJH  
Date Received04/09/1985
Decision Date 07/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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