510(k) K850382
K850382 is an FDA 510(k) premarket notification submitted by Radiation Safety & Nuclear Products, Inc. for the device "IRIDIUM SEEDS". The FDA issued a decision of Substantially Equivalent on August 15, 1985. The device falls under product code IWA (Source, Wire, Iridium, Radioactive), a Class II device regulated under 21 CFR 892.5730. Radiation Safety & Nuclear Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 1985
- Date Received
- February 1, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Source, Wire, Iridium, Radioactive
- Device Class
- Class II
- Regulation Number
- 892.5730
- Review Panel
- RA
- Submission Type