510(k) K043117
K043117 is an FDA 510(k) premarket notification submitted by Best Medical International, Inc. for the device "BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER". The FDA issued a decision of Substantially Equivalent on Dec 9, 2004. 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
- Dec 9, 2004
- Date Received
- Nov 10, 2004
- 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)