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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 K220102
Device Name MOST-T Autoclave
Applicant
Shinva Medical Instrument Co., Ltd.
Xinhua Medical Scientific Zone, Zibo New & Hi-Tech
Industrial Development Zone
Zibo,  CN 255086
Applicant Contact Liu Xiaolin
Correspondent
Guangzhou Osmunda Medical Device Technology, Inc.
9th Floor, R&D Bldg., # 26 Qinglan St.
Panyu District
Guangzhou,  CN 510006
Correspondent Contact Olivia Meng
Regulation Number880.6880
Classification Product Code
FLE  
Date Received01/12/2022
Decision Date 10/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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