510(k) K991571
K991571 is an FDA 510(k) premarket notification submitted by Alpha-Omega Services, Inc. for the device "10 CURIE IRDIUM 192, CSN00100-192". The FDA issued a decision of Substantially Equivalent on February 22, 2000. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Alpha-Omega Services, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2000
- Date Received
- May 5, 1999
- 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