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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K222151
Device Name Sterilization Wrap
Applicant
Kenpax International Limited
Flat 5, 5/F, Wing On Plz.,
62 Mody Rd. Tsim Sha Tsui, Kowloon
Hong Kong,  CN  999077
Applicant Contact Jerome Ren
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui, #5, Yihe N. Rd.
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number880.6850
Classification Product Code
FRG  
Date Received07/20/2022
Decision Date 03/23/2023
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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