510(k) K171239
K171239 is an FDA 510(k) premarket notification submitted by Tusker Medical for the device "TULA Tube Delivery System". The FDA issued a decision of Substantially Equivalent on June 28, 2017. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880. Tusker Medical has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 2017
- Date Received
- April 27, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tympanostomy
- Device Class
- Class II
- Regulation Number
- 874.3880
- Review Panel
- EN
- Submission Type