The following data is part of a premarket notification filed by Telectronics, Inc. with the FDA for Slimline Unipolar Endocardial Pacing Lead,#30-401.
| Device ID | K853221 |
| 510k Number | K853221 |
| Device Name: | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-401 |
| Classification | Permanent Pacemaker Electrode |
| 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 | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-01 |
| Decision Date | 1985-09-17 |