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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 K002165
Device Name LINEZOLID, 30UG, BBL SENSI-DISC
Applicant
Dickinson, and Co.
7 Loveton Circle
Sparks,  MD  21152
Applicant Contact BRADFORD SPRING
Correspondent
Dickinson, and Co.
7 Loveton Circle
Sparks,  MD  21152
Correspondent Contact BRADFORD SPRING
Regulation Number866.1620
Classification Product Code
JTN  
Date Received07/18/2000
Decision Date 09/05/2000
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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