510(k) K874787
K874787 is an FDA 510(k) premarket notification submitted by Theragenics Corp. for the device "MODIFIED PALLADIUM SEED MODEL 100". The FDA issued a decision of Substantially Equivalent on December 22, 1987. The device falls under product code IWI (Source, Isotope, Sealed, Gold, Titanium, Platinum), a Class II device regulated under 21 CFR 892.5730. Theragenics Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 1987
- Date Received
- November 23, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Source, Isotope, Sealed, Gold, Titanium, Platinum
- Device Class
- Class II
- Regulation Number
- 892.5730
- Review Panel
- RA
- Submission Type