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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, Selective Broth
510(k) Number K873218
Device Name BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802
Applicant
Lakewood Biochemical Co., Inc.
2111 Irving Blvd.
Dallas,  TX  75207
Applicant Contact JOHN E PEDIGO
Correspondent
Lakewood Biochemical Co., Inc.
2111 Irving Blvd.
Dallas,  TX  75207
Correspondent Contact JOHN E PEDIGO
Regulation Number866.2360
Classification Product Code
JSD  
Date Received08/14/1987
Decision Date 09/23/1987
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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