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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ldl & Vldl Precipitation, Hdl
510(k) Number K905284
Device Name HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173
Applicant
Amresco, Inc.
30175 Solon Industrial Pkwy.
Solon,  OH  44139
Applicant Contact PRAFUL PATEL
Correspondent
Amresco, Inc.
30175 Solon Industrial Pkwy.
Solon,  OH  44139
Correspondent Contact PRAFUL PATEL
Regulation Number862.1475
Classification Product Code
LBR  
Date Received11/23/1990
Decision Date 12/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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