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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 K871447
Device Name TODD HEWITT W/CNA (LIM BROTH)
Applicant
REMEL CO.
12076 SANTA FE DR.
LENEXA,  KS  66215
Applicant Contact JAMES G BAXENDALE
Correspondent
REMEL CO.
12076 SANTA FE DR.
LENEXA,  KS  66215
Correspondent Contact JAMES G BAXENDALE
Regulation Number866.2360
Classification Product Code
JSD  
Date Received04/13/1987
Decision Date 05/13/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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