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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K212554
Device Name Bonvadis Topical Cream
Applicant
Stemcyte, Inc.
13800 Live Oak Ave.
Baldwin Park,  CA  91706
Applicant Contact Angel Hsieh
Correspondent
Stemcyte, Inc.
13800 Live Oak Ave.
Baldwin Park,  CA  91706
Correspondent Contact Angel Hsieh
Classification Product Code
FRO  
Date Received08/13/2021
Decision Date 08/19/2022
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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