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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oral Wound Dressing
510(k) Number K173196
Device Name SUNTOUCH Dental Dressing
Applicant
Huizhou Foryou Medical Devices Co., Ltd.
North Shangxia Rd. Dongjiang Hi-Tech Industry Park
Huizhou,  CN 516005
Applicant Contact Junfeng Zhang
Correspondent
Huizhou Foryou Medical Devices Co., Ltd.
North Shangxia Rd. Dongjiang Hi-Tech Industry Park
Huizhou,  CN 516005
Correspondent Contact Junfeng Zhang
Classification Product Code
OLR  
Date Received10/02/2017
Decision Date 01/24/2018
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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