The following data is part of a premarket notification filed by Telectronics Pacing Systems, Inc. with the FDA for Universal Terminal Cap, 3.2mm.
| Device ID | K913919 |
| 510k Number | K913919 |
| Device Name: | UNIVERSAL TERMINAL CAP, 3.2MM |
| Classification | Materials, Repair Or Replacement, Pacemaker |
| Applicant | TELECTRONICS PACING SYSTEMS, INC. 7400 SOUTH TUCSON WAY Englewood, CO 80112 |
| Contact | Duane A Schultz |
| Correspondent | Duane A Schultz TELECTRONICS PACING SYSTEMS, INC. 7400 SOUTH TUCSON WAY Englewood, CO 80112 |
| Product Code | KFJ |
| CFR Regulation Number | 870.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-03 |
| Decision Date | 1991-12-31 |