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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K250164
Device Name Cassette Autoclave (ACA5)
Applicant
Guangzhou Ajax Medical Equipment Co., Ltd.
Bldg. #2
Dagang Industrial Zone, Shilou Town, Panyu District
Guangzhou,  CN 511493
Applicant Contact Dien Wang
Correspondent
Sgs-Cstc Standards Technical Services Co., Ltd.
198 Kezhu Rd. Scientech Park Guangzhou Economic
& Technology Development District
Guangzhou,  CN 510000
Correspondent Contact Iris Fung
Regulation Number880.6880
Classification Product Code
FLE  
Date Received01/21/2025
Decision Date 08/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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