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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

LT Antibacterial Foam with Silver Dressing

FDA 510(k) source

510(k) number
K254246
Applicant
Zhejiang Longterm Medical Technology Co., Ltd.
Decision date
Sep 10, 2026
Date received
Dec 29, 2025
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
NAD
Device type
Dressing, Wound, Occlusive
Device class
Class I
Regulation
21 CFR 878.4020
Advisory committee
General, Plastic Surgery
Statement or summary
Summary
Third party
N
Location
Deqing, CN