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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 K873267
Device Name ECG BASED MEDIA
Applicant
Central Media
10386 Rockingham Dr.
Sacramento,  CA  95827
Applicant Contact REBECCA CLARK
Correspondent
Central Media
10386 Rockingham Dr.
Sacramento,  CA  95827
Correspondent Contact REBECCA CLARK
Regulation Number866.2330
Classification Product Code
KZI  
Date Received08/11/1987
Decision Date 11/04/1987
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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