510(k) K060799
K060799 is an FDA 510(k) premarket notification submitted by Cosman Medical, Inc. for the device "COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA". The FDA issued a decision of Substantially Equivalent on May 2, 2006. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Cosman Medical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2006
- Date Received
- March 24, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Radiofrequency Lesion
- Device Class
- Class II
- Regulation Number
- 882.4725
- Review Panel
- NE
- Submission Type