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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 K243994
Device Name Steam Sterilizer (2545D)
Applicant
Ningbo Ican Machines Co., Ltd.
# 77 Yunlin E. Rd., Gulin Town,
Haishu District
Ningbo,  CN 315000
Applicant Contact Hui Lin
Correspondent
Orscene (Shanghai) Medical Technology Co., Ltd.
Rm. 118, Bldg. 20, # 1-42, Ln. 83, Hongxiang N. Rd.
Lingang New Zone, China (Shanghai) Pilot Free Trade Zone
Shanghai,  CN
Correspondent Contact Lord Guo
Regulation Number880.6880
Classification Product Code
FLE  
Date Received12/26/2024
Decision Date 06/06/2025
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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