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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clinical Sample Concentrator
510(k) Number K941326
Device Name ULTRAFREE-CL
Applicant
Millipore Corp.
80 Ashby Rd.
Bedford,  MA  01730
Applicant Contact THOMAS G BORROWS
Correspondent
Millipore Corp.
80 Ashby Rd.
Bedford,  MA  01730
Correspondent Contact THOMAS G BORROWS
Regulation Number862.2310
Classification Product Code
JJH  
Date Received03/18/1994
Decision Date 05/27/1994
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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