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FDA 510(k)

SiO2 Coated syringe 3 ml

K-Number: K153553 · 2016-05-17

ApplicantSio2 Medical Products
Decision Date2016-05-17
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SiO2 Coated syringe 3 ml is the device name listed in this FDA 510(k) record. The listed applicant is Sio2 Medical Products. It received FDA 510(k) clearance on 2016-05-17 under 510(k) number K153553. 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 SiO2 Coated syringe 3 ml?

SiO2 Coated syringe 3 ml is a medical device that received FDA 510(k) clearance on 2016-05-17. The listed applicant is Sio2 Medical Products. The 510(k) number is K153553.

When did SiO2 Coated syringe 3 ml receive FDA 510(k) clearance?

SiO2 Coated syringe 3 ml received FDA 510(k) clearance on 2016-05-17, under 510(k) number K153553.

Who is the listed applicant for SiO2 Coated syringe 3 ml?

The FDA 510(k) record lists Sio2 Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SiO2 Coated syringe 3 ml?

The FDA product code for SiO2 Coated syringe 3 ml is FMF.

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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