510(k) K160181
K160181 is an FDA 510(k) premarket notification submitted by Colorado Therapeutics, LLC for the device "COLORADO THERAPEUTICS XENOGRAFT IMPLANT". The FDA issued a decision of Substantially Equivalent on Oct 20, 2016. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Colorado Therapeutics, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 20, 2016
- Date Received
- Jan 27, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
- 510(k)