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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 K971120
Device Name DISPENS-O-DISC (TM) LEVOFLOXACIN
Applicant
Difco Laboratories, Inc.
920 Henry St.
Detroit,  MI  48201
Applicant Contact DAVID W GATES
Correspondent
Difco Laboratories, Inc.
920 Henry St.
Detroit,  MI  48201
Correspondent Contact DAVID W GATES
Regulation Number866.1620
Classification Product Code
JTN  
Date Received03/27/1997
Decision Date 04/14/1997
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
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