510(k) K061638
K061638 is an FDA 510(k) premarket notification submitted by Best Medical International, Inc. for the device "BEST STRAND AND BEST SPACER". The FDA issued a decision of Substantially Equivalent on Aug 4, 2006. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Best Medical International, Inc. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 4, 2006
- Date Received
- Jun 12, 2006
- Clearance Type
- Traditional
- 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
- 510(k)