The following data is part of a premarket notification filed by Cook Pacemaker Corp. with the FDA for Cook Pacemaker 33it R Unipolar Cardiac Pulse Gener.
| Device ID | K853651 |
| 510k Number | K853651 |
| Device Name: | COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER |
| 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 | 1985-09-03 |
| Decision Date | 1985-10-23 |