510(k) K761145
K761145 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "RADIOISOTOPE CALIBRATOR (CRCO-22NB)". The FDA issued a decision of Substantially Equivalent on Dec 16, 1976. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. G.D. Searle And Co. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 16, 1976
- Date Received
- Nov 26, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Stimulator, Electrical, Non-Implantable, For Incontinence
- Device Class
- Class II
- Regulation Number
- 876.5320
- Review Panel
- GU
- Submission Type
- 510(k)