510(k) K172318
K172318 is an FDA 510(k) premarket notification submitted by Aroa Biosurgery for the device "Endoform Silver Dermal Template". The FDA issued a decision of Substantially Equivalent on November 17, 2017. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Aroa Biosurgery has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 2017
- Date Received
- August 1, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type