510(k) K792256
K792256 is an FDA 510(k) premarket notification submitted by Keithley Development Co. for the device "KEITHLEY CLAMP". The FDA issued a decision of Substantially Equivalent on December 6, 1979. The device falls under product code EYR (Tourniquet, Gastro-Urology), a Class I device regulated under 21 CFR 878.5900. Keithley Development Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 1979
- Date Received
- November 9, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tourniquet, Gastro-Urology
- Device Class
- Class I
- Regulation Number
- 878.5900
- Review Panel
- SU
- Submission Type