510(k) K131851
K131851 is an FDA 510(k) premarket notification submitted by Osteomed for the device "OSTEOMED NEURO RONGEUR". The FDA issued a decision of Substantially Equivalent on December 6, 2013. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. Osteomed has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 2013
- Date Received
- June 21, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rongeur, Manual
- Device Class
- Class II
- Regulation Number
- 882.4840
- Review Panel
- NE
- Submission Type