510(k) K143605
K143605 is an FDA 510(k) premarket notification submitted by Isdin Corp. for the device "Nutraseb Facial Cream". The FDA issued a decision of Substantially Equivalent on Apr 14, 2016. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 14, 2016
- Date Received
- Dec 19, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)