FDA 510(k) Premarket Notification K203410: ENFit Disposable Enteral Syringe

Submission Details & Decision

Normalized public record details for 510(k) notification K203410.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K203410

Applicant / Sponsor

Shantou Wealy Medical Instrument Co.,Ltd

Device Name

ENFit Disposable Enteral Syringe

Product Code

PNR

Decision Date

2021-06-28

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Gastroenterology, Urology (GU)

Clearance Type

Traditional

Third Party Flag

Date Received

2020-11-19

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.