510(k) K233628
K233628 is an FDA 510(k) premarket notification submitted by Alpha-Omega Services, Inc. for the device "AOS Interstitial Templates, Needles, and Accessories". The FDA issued a decision of Substantially Equivalent on July 10, 2024. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Alpha-Omega Services, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2024
- Date Received
- November 13, 2023
- 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