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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 K871541
Device Name MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226
Applicant
Gibco Laboratories Life Technologies, Inc.
2801 Industrial Dr.
Madison,  WI  53713
Applicant Contact GREGG G BURMEISTER
Correspondent
Gibco Laboratories Life Technologies, Inc.
2801 Industrial Dr.
Madison,  WI  53713
Correspondent Contact GREGG G BURMEISTER
Regulation Number866.2410
Classification Product Code
JTY  
Date Received04/20/1987
Decision Date 04/29/1987
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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