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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, General Nutrient Broth
510(k) Number K841221
Device Name BRAIN HEART INFUSION BROTH
Applicant
Anaerobe Systems
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Anaerobe Systems
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2350
Classification Product Code
JSC  
Date Received03/22/1984
Decision Date 04/04/1984
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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