510(k) K881323
K881323 is an FDA 510(k) premarket notification submitted by Compagnie Oris Industrie, S.A. for the device "CURIETRON 192 LOW DOSE RATE". The FDA issued a decision of Substantially Equivalent on January 17, 1989. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Compagnie Oris Industrie, S.A. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1989
- Date Received
- March 28, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Applicator, Radionuclide, Remote-Controlled
- Device Class
- Class II
- Regulation Number
- 892.5700
- Review Panel
- RA
- Submission Type