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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 K864267
Device Name SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY)
Applicant
Millipore Corp.
34 Maple St.
Milford,  MA  01757
Applicant Contact MARQUAND RANSOM
Correspondent
Millipore Corp.
34 Maple St.
Milford,  MA  01757
Correspondent Contact MARQUAND RANSOM
Regulation Number862.2260
Classification Product Code
DPM  
Date Received10/29/1986
Decision Date 01/09/1987
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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