510(k) K100205
K100205 is an FDA 510(k) premarket notification submitted by Folsom Metal Products, Inc. for the device "FRONTIER DEVICES NEURO SYSTEM". The FDA issued a decision of Substantially Equivalent on Dec 13, 2010. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 13, 2010
- Date Received
- Jan 25, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Cranioplasty, Preformed, Alterable
- Device Class
- Class II
- Regulation Number
- 882.5320
- Review Panel
- NE
- Submission Type
- 510(k)