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510(k) clearance

Sterilization Cassette (CASS-1)

FDA 510(k) source

510(k) number
K262042
Applicant
Alliedstar Medical Equipment Co., Ltd.
Decision date
Oct 14, 2026
Date received
Jun 17, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
KCT
Device type
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device class
Class II
Regulation
21 CFR 880.6850
Advisory committee
General Hospital
Statement or summary
Summary
Third party
N
Location
Ziyang, CN