The following data is part of a premarket notification filed by Metronic, Inc. with the FDA for Model 4951m Myocardial Unipolar Lead.
| Device ID | K031210 |
| 510k Number | K031210 |
| Device Name: | MODEL 4951M MYOCARDIAL UNIPOLAR LEAD |
| Classification | Permanent Pacemaker Electrode |
| Applicant | METRONIC, INC. 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Contact | Tina Benoit |
| Correspondent | Tina Benoit METRONIC, INC. 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-17 |
| Decision Date | 2003-05-16 |
| Summary: | summary |