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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Instrumentation, High Pressure Liquid Chromatography
510(k) Number K903647
Device Name MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE
Applicant
Millipore Corp.
34 Maple St.
Milford,  MA  01757
Applicant Contact MARQUAND S RANDOM
Correspondent
Millipore Corp.
34 Maple St.
Milford,  MA  01757
Correspondent Contact MARQUAND S RANDOM
Regulation Number862.2260
Classification Product Code
LDM  
Date Received08/09/1990
Decision Date 09/11/1990
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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