Disposable Pen Injector Assembly
K-Number: K240961 · 2024-08-15
ApplicantWuxi Nest Biotechnology Co., Ltd.
Decision Date2024-08-15
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Disposable Pen Injector Assembly is a medical device manufactured by Wuxi Nest Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-15 under approval number K240961. 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 Disposable Pen Injector Assembly?
Disposable Pen Injector Assembly is a medical device that received FDA 510(k) clearance on 2024-08-15. It is manufactured by Wuxi Nest Biotechnology Co., Ltd.. The 510(k) number is K240961.
When was Disposable Pen Injector Assembly approved by the FDA?
Disposable Pen Injector Assembly received FDA 510(k) clearance on 2024-08-15, under approval number K240961.
What company makes Disposable Pen Injector Assembly?
Disposable Pen Injector Assembly is manufactured by Wuxi Nest Biotechnology Co., Ltd..
What is the FDA product code for Disposable Pen Injector Assembly?
The FDA product code for Disposable Pen Injector Assembly is FMF.
Other Devices by Wuxi Nest Biotechnology Co., Ltd.
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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.