The following data is part of a premarket notification filed by Arco Medical Products Co. with the FDA for External Silastic Boot For Cardiac Pulse.
| Device ID | K801806 |
| 510k Number | K801806 |
| Device Name: | EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | ARCO MEDICAL PRODUCTS CO. 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 | 1980-07-30 |
| Decision Date | 1980-09-09 |