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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Transducer, Dialysis
510(k) Number K934069
Device Name MILLEX, DUALEX (PLUS, ULTRA)
Applicant
Millipore Corp.
80 Ashby Rd.
P.O. Box 9125
Bedford,  MA  01730
Applicant Contact THOMAS G BORROWS
Correspondent
Millipore Corp.
80 Ashby Rd.
P.O. Box 9125
Bedford,  MA  01730
Correspondent Contact THOMAS G BORROWS
Regulation Number876.5820
Classification Product Code
FIB  
Date Received08/20/1993
Decision Date 04/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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