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FDA 510(k)

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

K-Number: K210200 · 2021-05-14

ApplicantSet Medikal Sanayi VE Ticaret Anonim Sirketi
Decision Date2021-05-14
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock is the device name listed in this FDA 510(k) record. The listed applicant is Set Medikal Sanayi VE Ticaret Anonim Sirketi. It received FDA 510(k) clearance on 2021-05-14 under 510(k) number K210200. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock?

1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock is a medical device that received FDA 510(k) clearance on 2021-05-14. The listed applicant is Set Medikal Sanayi VE Ticaret Anonim Sirketi. The 510(k) number is K210200.

When did 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock receive FDA 510(k) clearance?

1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock received FDA 510(k) clearance on 2021-05-14, under 510(k) number K210200.

Who is the listed applicant for 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock?

The FDA 510(k) record lists Set Medikal Sanayi VE Ticaret Anonim Sirketi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock?

The FDA product code for 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock is FMF.

Other records listing Set Medikal Sanayi VE Ticaret Anonim Sirketi as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201284Sterile 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

Related Devices (Code: FMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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