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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, Enriched
510(k) Number K864014
Device Name LOMBARD DOWELL AGAR BASE
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 Number866.2330
Classification Product Code
KZI  
Date Received10/15/1986
Decision Date 10/29/1986
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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