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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Supplement, Culture Media
510(k) Number K790801
Device Name STERILE DEFIBRINATED SHEEP BLOOD
Applicant
Central Biological Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Central Biological Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2450
Classification Product Code
JSK  
Date Received04/19/1979
Decision Date 05/03/1979
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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