510(k) K210200

1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock by Set Medikal Sanayi VE Ticaret Anonim Sirketi — Product Code FMF

K210200 is an FDA 510(k) premarket notification submitted by Set Medikal Sanayi VE Ticaret Anonim Sirketi for the device "1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock". The FDA issued a decision of Substantially Equivalent on May 14, 2021. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Set Medikal Sanayi VE Ticaret Anonim Sirketi has 1 other 510(k) clearance on record.