The following data is part of a premarket notification filed by Pace Medical with the FDA for Model 4205 Pulse Generator Surgical Exten Cable.
| Device ID | K912545 |
| 510k Number | K912545 |
| Device Name: | MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE |
| Classification | Implantable Pacemaker Pulse-generator |
| 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 | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-10 |
| Decision Date | 1991-07-26 |