510(k) K034062
K034062 is an FDA 510(k) premarket notification submitted by Cp Medical for the device "CP SLEEVE AND RIVER SLEEVE". The FDA issued a decision of Substantially Equivalent on January 30, 2004. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Cp Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2004
- Date Received
- December 31, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Source, Brachytherapy, Radionuclide
- Device Class
- Class II
- Regulation Number
- 892.5730
- Review Panel
- RA
- Submission Type