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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

Safety lancet (XL)

FDA 510(k) source

510(k) number
K262526
Applicant
Tianjin Huahong Technology Co., Ltd.
Decision date
Sep 13, 2026
Date received
Jul 22, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
FMK
Device type
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device class
Class II
Regulation
21 CFR 878.4850
Advisory committee
General, Plastic Surgery
Statement or summary
Summary
Third party
N
Location
Tianjin, CN