The following data is part of a premarket notification filed by Telectronics, Inc. with the FDA for Vs-1 Silicone Implant Leads (new Serial # Tube).
| Device ID | K890350 |
| 510k Number | K890350 |
| Device Name: | VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) |
| Classification | Permanent Pacemaker Electrode |
| Applicant | TELECTRONICS, INC. 7400 TUSCON WAY Englewood, CO 80112 |
| Contact | A Schultz |
| Correspondent | A Schultz TELECTRONICS, INC. 7400 TUSCON WAY Englewood, CO 80112 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-08 |
| Decision Date | 1989-02-02 |