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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cells, Animal And Human, Cultured
510(k) Number K871613
Device Name BUFFALO GREEN MONKEY KIDNEY CELLS
Applicant
Viromed Laboratories, Inc.
5100 Gamble Dr.
Suite 55
Minneapolis,  MN  55416
Applicant Contact BONITA L BASKIN,PHD
Correspondent
Viromed Laboratories, Inc.
5100 Gamble Dr.
Suite 55
Minneapolis,  MN  55416
Correspondent Contact BONITA L BASKIN,PHD
Regulation Number864.2280
Classification Product Code
KIR  
Date Received04/24/1987
Decision Date 05/13/1987
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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