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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alcohol Control Materials
510(k) Number K843872
Device Name ETHANOL CONTROLS LOW & HIGH E5133/E5258
Applicant
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Applicant Contact LEO BRESSLER
Correspondent
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Correspondent Contact LEO BRESSLER
Regulation Number862.3280
Classification Product Code
DKC  
Date Received10/02/1984
Decision Date 10/31/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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