The following data is part of a premarket notification filed by Cook Pacemaker Corp. with the FDA for Miniflex Model 340, 341, And 342 Pulse Generators.
| Device ID | K953417 |
| 510k Number | K953417 |
| Device Name: | MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | COOK PACEMAKER CORP. P.O. BOX 529 ROUTE 66 RIVER ROAD Leechburg, PA 15656 -0529 |
| Contact | Richyard E Shirey |
| Correspondent | Richyard E Shirey COOK PACEMAKER CORP. P.O. BOX 529 ROUTE 66 RIVER ROAD Leechburg, PA 15656 -0529 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-08 |
| Decision Date | 1995-09-29 |