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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 K951440
Device Name LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE
Applicant
Viromed Laboratories, Inc.
6101 Blue Circle Dr.
Minnetonka,  MN  55343 -7920
Applicant Contact MERCEDES P BAYANI
Correspondent
Viromed Laboratories, Inc.
6101 Blue Circle Dr.
Minnetonka,  MN  55343 -7920
Correspondent Contact MERCEDES P BAYANI
Regulation Number864.2280
Classification Product Code
KIR  
Date Received03/29/1995
Decision Date 05/22/1996
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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