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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Suspension, Cell Culture
510(k) Number K892645
Device Name AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY
Applicant
Amicon, Inc.
17 Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact JAMES M DELANEY
Correspondent
Amicon, Inc.
17 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact JAMES M DELANEY
Regulation Number864.2240
Classification Product Code
KJF  
Date Received04/12/1989
Decision Date 06/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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