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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Tubes With Enteral Specific Connectors
510(k) Number K242917
Device Name Enteral Drainage System, Enteral Medicine straw
Applicant
Hmc Premedical S.P.A.
Via Bosco, 1/3
Mirandola,  IT 41037
Applicant Contact Danilo Bosetti
Correspondent
Hmc Premedical S.P.A.
Via Bosco, 1/3
Mirandola,  IT 41037
Correspondent Contact Danilo Bosetti
Regulation Number876.5980
Classification Product Code
PIF  
Date Received09/24/2024
Decision Date 06/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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