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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, Propagating Transport
510(k) Number K792201
Device Name STREP CULTURETTE
Applicant
Marion Health & Safety, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Marion Health & Safety, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2390
Classification Product Code
JSN  
Date Received11/02/1979
Decision Date 11/30/1979
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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