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Parker Quality & Compliance

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510(k) clearance

Foster Plus-22L (SNK/CE-F22)

FDA 510(k) source

510(k) number
K260354
Applicant
Zhejiang Fomos Medical Technology Co., Ltd.
Decision date
Oct 30, 2026
Date received
Feb 3, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
FLE
Device type
Sterilizer, Steam
Device class
Class II
Regulation
21 CFR 880.6880
Advisory committee
General Hospital
Statement or summary
Summary
Third party
N
Location
Zhejiang, CN