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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Susceptibility Test Discs, Antimicrobial
510(k) Number K964491
Device Name NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
Applicant
UNIPATH LTD.
15 OAK ST.
BEVERLY FARMS,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
UNIPATH LTD.
15 OAK ST.
BEVERLY FARMS,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number866.1620
Classification Product Code
JTN  
Date Received11/07/1996
Decision Date 02/07/1997
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
Recalls CDRH Recalls
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