510(k) K874895
K874895 is an FDA 510(k) premarket notification submitted by Rads S.L., Inc. for the device "IR-192 IMPLANT". The FDA issued a decision of Substantially Equivalent on February 25, 1988. The device falls under product code IWA (Source, Wire, Iridium, Radioactive), a Class II device regulated under 21 CFR 892.5730. Rads S.L., Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1988
- Date Received
- December 1, 1987
- 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