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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 Powders, Antimicrobial
510(k) Number K864442
Device Name NORFLOXACIN SUSCEPTIBILITY POWDER
Applicant
Merck, Sharp & Dohme
Division Of Merck & Co., Inc.
West Point,  PA  19486
Applicant Contact BLOIS, PHD
Correspondent
Merck, Sharp & Dohme
Division Of Merck & Co., Inc.
West Point,  PA  19486
Correspondent Contact BLOIS, PHD
Regulation Number866.1640
Classification Product Code
JTT  
Date Received11/12/1986
Decision Date 12/11/1986
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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