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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 K201284
Device Name Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use
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 Received05/13/2020
Decision Date 12/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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