Prefilled Syringe
K-Number: K202698 · 2020-12-15
ApplicantHangzhou Primecare Medical Co., Ltd.
Decision Date2020-12-15
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Prefilled Syringe is a medical device manufactured by Hangzhou Primecare Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-12-15 under approval number K202698. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Prefilled Syringe?
Prefilled Syringe is a medical device that received FDA 510(k) clearance on 2020-12-15. It is manufactured by Hangzhou Primecare Medical Co., Ltd.. The 510(k) number is K202698.
When was Prefilled Syringe approved by the FDA?
Prefilled Syringe received FDA 510(k) clearance on 2020-12-15, under approval number K202698.
What company makes Prefilled Syringe?
Prefilled Syringe is manufactured by Hangzhou Primecare Medical Co., Ltd..
What is the FDA product code for Prefilled Syringe?
The FDA product code for Prefilled Syringe is EZL.
Related Clinical Trials
Other Devices by Hangzhou Primecare Medical 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.