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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 K883075
Device Name FASTIDIOUS INOCULUM BROTH
Applicant
Baxter Healthcare Corp
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact WEAVER HUFFMAN
Correspondent
Baxter Healthcare Corp
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact WEAVER HUFFMAN
Regulation Number866.2360
Classification Product Code
JSD  
Date Received07/13/1988
Decision Date 08/15/1988
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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