The following data is part of a premarket notification filed by Pace Medical with the FDA for Model 3110 Heart Wire & 3110p Pediatric Heart Wire.
| Device ID | K890988 |
| 510k Number | K890988 |
| Device Name: | MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
| Contact | Ralph E Hanson |
| Correspondent | Ralph E Hanson PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-27 |
| Decision Date | 1989-08-25 |