510(k) K130541
K130541 is an FDA 510(k) premarket notification submitted by Symmetry Surgical for the device "SYMMETRY KERRISON DISPOSABLE TIP RONGEURS". The FDA issued a decision of Substantially Equivalent on August 5, 2013. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. Symmetry Surgical has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 2013
- Date Received
- March 1, 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