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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluid, Bouin'S
510(k) Number K833515
Device Name BOUINS SOLUTION
Applicant
Sigma Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sigma Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.4010
Classification Product Code
IGN  
Date Received10/11/1983
Decision Date 11/14/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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