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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, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
510(k) Number K811049
Device Name MUELLER HINTON AGAR
Applicant
Acumedia Manufacturers, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Acumedia Manufacturers, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.1700
Classification Product Code
JTZ  
Date Received04/16/1981
Decision Date 04/29/1981
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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