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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 K833359
Device Name WI-38 CELLS
Applicant
Biocon, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Biocon, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.2280
Classification Product Code
KIR  
Date Received09/28/1983
Decision Date 11/03/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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