510(k) K922899
K922899 is an FDA 510(k) premarket notification submitted by Pace Medical for the device "MODEL 4280 SURGICAL EXTENSION CABLE". The FDA issued a decision of Substantially Equivalent on December 23, 1992. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Pace Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 1992
- Date Received
- June 16, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cable, Transducer And Electrode, Patient, (Including Connector)
- Device Class
- Class II
- Regulation Number
- 870.2900
- Review Panel
- CV
- Submission Type