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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chromatography (Liquid, Gel), Clinical Use
510(k) Number K905538
Device Name COLUMNS LIQUID CHROMATOGRAPHY DPM
Applicant
Millpore Corp.
Waters Chromatography Division
34 Maple St.
Milford,  MA  01757
Applicant Contact MARQUAND S RANSOM
Correspondent
Millpore Corp.
Waters Chromatography Division
34 Maple St.
Milford,  MA  01757
Correspondent Contact MARQUAND S RANSOM
Regulation Number862.2260
Classification Product Code
KZR  
Date Received12/11/1990
Decision Date 01/25/1991
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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