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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Antimicrobial Susceptibility Test Systems
510(k) Number K896332
Device Name SUPPLEMENT TO ANAEROBIC MIC PANEL
Applicant
Microtech Medical Systems, Inc.
401 Laredo St., Unit 1
Aurora,  CO  80011
Applicant Contact JERRY G KILGORE
Correspondent
Microtech Medical Systems, Inc.
401 Laredo St., Unit 1
Aurora,  CO  80011
Correspondent Contact JERRY G KILGORE
Regulation Number866.1640
Classification Product Code
JWY  
Date Received11/02/1989
Decision Date 02/05/1990
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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