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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 K924347
Device Name WATERS(TM) 996 PDA
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 Received08/27/1992
Decision Date 12/11/1992
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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