Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe— 510(k) K213013

Substantially Equivalent

Jeil Tech Co., Ltd.

FDA 510(k) clearance K213013 for Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe, Substantially Equivalent on 2022-09-19. Applicant: Jeil Tech Co., Ltd.. Device class: 2.

Clearance details

Applicant
Jeil Tech Co., Ltd.
Product code
Code QNQ
Device class
Class 2
Regulation
21 CFR 880.5860
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sejong-Si, KR
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