510(k) K945383
K945383 is an FDA 510(k) premarket notification submitted by Varian Assoc., Inc. for the device "HIGH DOSE RATE AFTERLOADER". The FDA issued a decision of Substantially Equivalent on February 15, 1995. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Varian Assoc., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 15, 1995
- Date Received
- October 25, 1994
- 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