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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K230610
Device Name Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)
Applicant
Dongguan Shin YI Healthcare Products Factory
# 17 Ban Hu Rd., Huang Jiang Town
Dong Guan,  CN 523750
Applicant Contact Shuge Zhao
Correspondent
Manton Business and Technology Services
37 Winding Ridge
Oakland,  NJ  07436
Correspondent Contact Melody Huang
Regulation Number878.4040
Classification Product Code
FYA  
Date Received03/06/2023
Decision Date 08/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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