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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solution, Antimicrobial
510(k) Number K900455
Device Name ZEFAZONE SUSCEPTIBILITY POWDER
Applicant
The Upjohn Co.
7000 Portage Rd.
Kalamazoo,  MI  49001
Applicant Contact MASON, PH.D.
Correspondent
The Upjohn Co.
7000 Portage Rd.
Kalamazoo,  MI  49001
Correspondent Contact MASON, PH.D.
Regulation Number866.1640
Classification Product Code
LOP  
Date Received01/30/1990
Decision Date 02/09/1990
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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