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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Cholinesterase
510(k) Number K051444
Device Name SENTINEL CHOLINESTERASE LIQUID
Applicant
Sentinel Ch. Srl
5 Via Principe Eugenio
Milano,  IT 20155
Applicant Contact DAVIDE SPADA
Correspondent
Sentinel Ch. Srl
5 Via Principe Eugenio
Milano,  IT 20155
Correspondent Contact DAVIDE SPADA
Regulation Number862.3240
Classification Product Code
DIH  
Date Received06/02/2005
Decision Date 06/20/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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