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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Primecare Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-12-15 under 510(k) 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. The listed applicant is Hangzhou Primecare Medical Co., Ltd.. The 510(k) number is K202698.

When did Prefilled Syringe receive FDA 510(k) clearance?

Prefilled Syringe received FDA 510(k) clearance on 2020-12-15, under 510(k) number K202698.

Who is the listed applicant for Prefilled Syringe?

The FDA 510(k) record lists Hangzhou Primecare Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prefilled Syringe?

The FDA product code for Prefilled Syringe is EZL.

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.

NCT06918587A Comparative Evaluation of Pharmacokinetics and Immunogenicity.COMPLETED

Other records listing Hangzhou Primecare Medical Co., Ltd. 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.

K240039Enteral Feeding Sets

Related Devices (Code: EZL)

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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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