The following data is part of a premarket notification filed by Telectronics, Inc. with the FDA for Implantable Electrode Adaptor Assembly.
| Device ID | K854997 |
| 510k Number | K854997 |
| Device Name: | IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY |
| Classification | Pacemaker Lead Adaptor |
| Applicant | TELECTRONICS, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
| Contact | William C Nealon |
| Correspondent | William C Nealon TELECTRONICS, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-12 |
| Decision Date | 1986-02-12 |