510(k) K131963
K131963 is an FDA 510(k) premarket notification submitted by Tautona Group, LLC for the device "TAUTONA INJECTOR DEVICE". The FDA issued a decision of Substantially Equivalent on October 22, 2013. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Tautona Group, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2013
- Date Received
- June 27, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type