The following data is part of a premarket notification filed by Stanco Medical, Inc. with the FDA for Atrial-ventricular Pacing Electrode Kit.
| Device ID | K810642 |
| 510k Number | K810642 |
| Device Name: | ATRIAL-VENTRICULAR PACING ELECTRODE KIT |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | STANCO MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-10 |
| Decision Date | 1981-04-08 |