510(k) K162017
K162017 is an FDA 510(k) premarket notification submitted by Biotd S.A. for the device "Ross Ru Wound Dressing Gel". The FDA issued a decision of Substantially Equivalent on Apr 20, 2017. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Biotd S.A. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 20, 2017
- Date Received
- Jul 21, 2016
- 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)