510(k) K132097
K132097 is an FDA 510(k) premarket notification submitted by Best Medical International, Inc. for the device "BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY". The FDA issued a decision of Substantially Equivalent on Sep 30, 2013. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Best Medical International, Inc. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 30, 2013
- Date Received
- Jul 8, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Applicator, Radionuclide, Remote-Controlled
- Device Class
- Class II
- Regulation Number
- 892.5700
- Review Panel
- RA
- Submission Type
- 510(k)