510(k) K955722
K955722 is an FDA 510(k) premarket notification submitted by Davis & Geck, Inc. for the device "FLEXON TEMPORARY CARDIAC PACER LEAD". The FDA issued a decision of Substantially Equivalent on March 15, 1996. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Davis & Geck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 1996
- Date Received
- December 18, 1995
- 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