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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K252279
Device Name Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 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 Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
PNR  
Date Received07/22/2025
Decision Date 04/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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