510(k) K810643
K810643 is an FDA 510(k) premarket notification submitted by Stanco Medical, Inc. for the device "UNIVERSAL PACING ELECTRODE KIT". The FDA issued a decision of Substantially Equivalent on April 8, 1981. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Stanco Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 1981
- Date Received
- March 10, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Pacemaker, Temporary
- Device Class
- Class II
- Regulation Number
- 870.3680
- Review Panel
- CV
- Submission Type