The following data is part of a premarket notification filed by Cook Pacemaker Corp. with the FDA for Jain Insulating Boot Model 225b.
| Device ID | K822652 |
| 510k Number | K822652 |
| Device Name: | JAIN INSULATING BOOT MODEL 225B |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | COOK PACEMAKER CORP. 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 | 1982-09-02 |
| Decision Date | 1982-10-04 |