510(k) K922899

MODEL 4280 SURGICAL EXTENSION CABLE by Pace Medical — Product Code DSA

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