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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calprotectin, Fecal
510(k) Number K191592
Device Name CalprestNG, EasyCal
Applicant
Eurospital S.P.A.
Via Flavia 122
Trieste,  IT 34147
Applicant Contact Chiara Pelillo
Correspondent
Eurospital S.P.A.
Via Flavia 122
Trieste,  IT 34147
Correspondent Contact Chiara Pelillo
Regulation Number866.5180
Classification Product Code
NXO  
Date Received06/14/2019
Decision Date 07/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
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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