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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, High Pressure Liquid Chromatography
510(k) Number K914841
Device Name CHROMATOGRAPHY CLINICAL USE 75JQR
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
KIE  
Date Received10/25/1991
Decision Date 12/10/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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