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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enteral Syringes With Enteral Specific Connectors
510(k) Number K252483
Device Name Enteral Syringe (20ml, 60ml)
Applicant
Chirana T.Injecta,A.S.
Nám.Dr.A.Schweitzera 194
Stará Turá,  SK 916 01
Applicant Contact Rastislav Broska
Correspondent
Chirana T.Injecta,A.S.
Nám.Dr.A.Schweitzera 194
Stará Turá,  SK 916 01
Correspondent Contact Rastislav Broska
Regulation Number876.5980
Classification Product Code
PNR  
Date Received08/07/2025
Decision Date 07/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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