FDA 510(k)

STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE

K-Number: K090929 · 2009-06-12

ApplicantShanghai Double Dove Industrial Co., Ltd.

Decision Date2009-06-12

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Double Dove Industrial Co., Ltd.. It received FDA 510(k) clearance on 2009-06-12 under 510(k) number K090929. 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 STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE?

STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE is a medical device that received FDA 510(k) clearance on 2009-06-12. The listed applicant is Shanghai Double Dove Industrial Co., Ltd.. The 510(k) number is K090929.

When did STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE receive FDA 510(k) clearance?

STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE received FDA 510(k) clearance on 2009-06-12, under 510(k) number K090929.

Who is the listed applicant for STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE?

The FDA 510(k) record lists Shanghai Double Dove Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE?

The FDA product code for STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE is FMF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Shanghai Double Dove Industrial Co., Ltd. as applicant

K120420STERILE BLUNT FOR SINGLE USE

Related Devices (Code: FMF)

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC K253110Sol-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.

Official Source

View on FDA Database →

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