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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 K210200
Device Name 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock
Applicant
Set Medikal Sanayi VE Ticaret Anonim Sirketi
Osmangazi Mahallesi Maresal Fevzi Cakmak Caddesi #18
Esenyurt
Istanbul,  TR 34522
Applicant Contact Mehice Ozturk
Correspondent
Medcer Uluslararasi Medikal Belgelendirme Anonim Sirketi
Taspinar Mahallesi 2800. Caddesi A-2 Apt. No:6 B/49
Ankara,  TR 06830
Correspondent Contact Mehmet Fatih Ormeci
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received01/25/2021
Decision Date 05/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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