The following data is part of a premarket notification filed by Pace Medical with the FDA for Models 4201, 4231 & 4235 Extension Cables.
| Device ID | K902679 |
| 510k Number | K902679 |
| Device Name: | MODELS 4201, 4231 & 4235 EXTENSION CABLES |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
| Contact | Robert C Mace |
| Correspondent | Robert C Mace PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-19 |
| Decision Date | 1990-07-19 |