510(k) K130447
K130447 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "SPEEDY FLAP SYSTEM". The FDA issued a decision of Substantially Equivalent on Dec 22, 2014. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. Jeil Medical Corporation has 52 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 22, 2014
- Date Received
- Feb 21, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Plate, Cranioplasty, Preformed, Non-Alterable
- Device Class
- Class II
- Regulation Number
- 882.5330
- Review Panel
- NE
- Submission Type
- 510(k)