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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 K250733
Device Name 3DOSE 1ml Syringe
Applicant
Bimed Teknik Aletler Sanayi & Ticaret A.S.
Beylikduzu Osb Mah. Leylak Cd. No:16 Beylikduzu/Istanbul
Istanbul,  TR 34520
Applicant Contact Aysel Kilic
Correspondent
Bimed Teknik Aletler Sanayi & Ticaret A.S.
Beylikduzu Osb Mah. Leylak Cd. No:16 Beylikduzu/Istanbul
Istanbul,  TR 34520
Correspondent Contact Aysel Kilic
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/11/2025
Decision Date 07/03/2025
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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