The following data is part of a premarket notification filed by Cook Pacemaker Corp. with the FDA for Model 340 Series Unipolar & Model 5000b Programmer.
| Device ID | K905403 |
| 510k Number | K905403 |
| Device Name: | MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | COOK PACEMAKER CORP. P.O. BOX 529 Leechburg, PA 15656 |
| Contact | Richard E Shirey |
| Correspondent | Richard E Shirey COOK PACEMAKER CORP. P.O. BOX 529 Leechburg, PA 15656 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-03 |
| Decision Date | 1991-10-16 |