wettrust D2care
FDA 510(k) clearance K170797 · decided 2017-12-06
Clearance details
- K-number
- K170797
- Device name
- wettrust D2care
- Applicant
- Wettrust Korea Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-03-17
- Decision date
- 2017-12-06
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- NUC
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Seongnam, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.