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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas Chromatograph, Carbon-Monoxide
510(k) Number K823535
Device Name DILUENT, ZEROING SOLUTION & CO-OX/ISE
Applicant
Shaban Mfg. Co.
MD 
Correspondent
Shaban Mfg. Co.
MD 
Regulation Number862.3220
Classification Product Code
JKT  
Date Received11/30/1982
Decision Date 01/28/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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