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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrumentation, High Pressure Liquid Chromatography
510(k) Number K850359
Device Name WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D
Applicant
Millipore Corp.
34 Maple St.
Milford,  MA  01757
Applicant Contact MARQUAND S RANSOM
Correspondent
Millipore Corp.
34 Maple St.
Milford,  MA  01757
Correspondent Contact MARQUAND S RANSOM
Regulation Number862.2260
Classification Product Code
LDM  
Date Received01/30/1985
Decision Date 03/05/1985
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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