The following data is part of a premarket notification filed by Telectronics, Inc. with the FDA for Implant Program Cardiac Pulse Gen W/mod Set Screw.
| Device ID | K853206 |
| 510k Number | K853206 |
| Device Name: | IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | TELECTRONICS, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
| Contact | Wiliiam C Nealon |
| Correspondent | Wiliiam C Nealon TELECTRONICS, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-31 |
| Decision Date | 1985-09-12 |