510(k) K852542
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 1986
- Date Received
- June 14, 1985
- 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