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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K262042
Device Name Sterilization Cassette (CASS-1)
Applicant
Alliedstar Medical Equipment Co., Ltd.
Floor 3-4, Unit 2, Bldg. 3, #222, W. Third Section, Waihuan
Yanjiang District
Ziyang,  CN 641300
Applicant Contact Jinyun Wang
Correspondent
Straumann USA, LLC
60 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Jennifer Jackson
Regulation Number880.6850
Classification Product Code
KCT  
Date Received06/17/2026
Decision Date 10/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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