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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 K964588
Device Name WATERS 515 HPLC PUMP (515)
Applicant
Waters Corporation
34 Maple St.
Milford,  MA  01757
Applicant Contact VIRGINIA L CORBIN
Correspondent
Waters Corporation
34 Maple St.
Milford,  MA  01757
Correspondent Contact VIRGINIA L CORBIN
Regulation Number862.2260
Classification Product Code
KIE  
Date Received11/15/1996
Decision Date 11/29/1996
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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