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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Non-Selective And Non-Differential
510(k) Number K791628
Device Name BRAIN HEART INFUSION AGAR 5% SHEEP BLOOD
Applicant
Isle Media and Sterile Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Isle Media and Sterile Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2300
Classification Product Code
JSG  
Date Received08/21/1979
Decision Date 09/27/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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