SUNTOUCH Dental Dressing— 510(k) K173196
Substantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.
FDA 510(k) clearance K173196 for SUNTOUCH Dental Dressing, Substantially Equivalent on 2018-01-24. Applicant: Huizhou Foryou Medical Devices Co., Ltd.. Device class: Unclassified.
Clearance details
- Applicant
- Huizhou Foryou Medical Devices Co., Ltd.
- Product code
- Code OLR
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Huizhou, CN
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Adverse events under product code OLR
product code OLR- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.