The following data is part of a premarket notification filed by Medcor, Inc. with the FDA for Lithicron 0520 P-synchroneous Pulse Gen..
| Device ID | K792609 |
| 510k Number | K792609 |
| Device Name: | LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN. |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | MEDCOR, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-18 |
| Decision Date | 1980-11-19 |