510(k) K913919
K913919 is an FDA 510(k) premarket notification submitted by Telectronics Pacing Systems, Inc. for the device "UNIVERSAL TERMINAL CAP, 3.2MM". The FDA issued a decision of Substantially Equivalent on December 31, 1991. The device falls under product code KFJ (Materials, Repair Or Replacement, Pacemaker), a Class III device regulated under 21 CFR 870.3710. Telectronics Pacing Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 1991
- Date Received
- September 3, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Materials, Repair Or Replacement, Pacemaker
- Device Class
- Class III
- Regulation Number
- 870.3710
- Review Panel
- CV
- Submission Type