SUNTOUCH Dental Dressing

Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

Huizhou Foryou Medical Devices Co., Ltd.

The following data is part of a premarket notification filed by Huizhou Foryou Medical Devices Co., Ltd. with the FDA for Suntouch Dental Dressing.

Pre-market Notification Details

Device IDK173196
510k NumberK173196
Device Name:SUNTOUCH Dental Dressing
ClassificationDressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Applicant Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd., Dongjiang Hi-tech Industry Park Huizhou,  CN 516005
ContactJunfeng Zhang
CorrespondentJunfeng Zhang
Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd., Dongjiang Hi-tech Industry Park Huizhou,  CN 516005
Product CodeMGQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-02
Decision Date2018-01-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20686864054683 K173196 000
20686864055086 K173196 000
00686864060215 K173196 000
20686864060776 K173196 000

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