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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, For Isolation Of Pathogenic Neisseria
510(k) Number K791398
Device Name CULTURE MEDIA FOR INSOLATION NEISSERIA
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 Number866.2410
Classification Product Code
JTY  
Date Received07/24/1979
Decision Date 08/22/1979
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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