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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Columns, Liquid Chromatography
510(k) Number K895105
Device Name HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE
Applicant
Waters Chemical Products
34 Maple St.
Milford,  MA  01757
Applicant Contact MARQUAND RANSOM
Correspondent
Waters Chemical Products
34 Maple St.
Milford,  MA  01757
Correspondent Contact MARQUAND RANSOM
Regulation Number862.2260
Classification Product Code
DPM  
Date Received08/15/1989
Decision Date 10/06/1989
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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