510(k) K020176
K020176 is an FDA 510(k) premarket notification submitted by Mick Radio-Nuclear Instruments, Inc. for the device "HDR MIAMI APPLICATOR". The FDA issued a decision of Substantially Equivalent on April 8, 2002. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Mick Radio-Nuclear Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2002
- Date Received
- January 18, 2002
- 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