1 Ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock

Syringe, Piston

Set Medikal Sanayi Ve Ticaret Anonim Sirketi

The following data is part of a premarket notification filed by Set Medikal Sanayi Ve Ticaret Anonim Sirketi with the FDA for 1 Ml Sterile Hypodermic Syringe For Single Use. With/without Needle. Luer/luer-lock.

Pre-market Notification Details

Device IDK210200
510k NumberK210200
Device Name:1 Ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock
ClassificationSyringe, Piston
Applicant Set Medikal Sanayi Ve Ticaret Anonim Sirketi Osmangazi Mahallesi Maresal Fevzi Cakmak Caddesi No.18 Esenyurt Istanbul,  TR 34522
ContactMehice Ozturk
CorrespondentMehmet Fatih Ormeci
Medcer Uluslararasi Medikal Belgelendirme Anonim Sirketi Taspinar Mahallesi 2800. Caddesi A-2 Apt. No:6 B/49 Ankara,  TR 06830
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-25
Decision Date2021-05-14

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