The following data is part of a premarket notification filed by Telectronics, Inc. with the FDA for Implantable Adaptor 033-380.
| Device ID | K890895 |
| 510k Number | K890895 |
| Device Name: | IMPLANTABLE ADAPTOR 033-380 |
| Classification | Pacemaker Lead Adaptor |
| Applicant | TELECTRONICS, INC. 7400 TUSCON WAY Englewood, CO 80112 |
| Contact | Duane A Schultz |
| Correspondent | Duane A Schultz TELECTRONICS, INC. 7400 TUSCON WAY Englewood, CO 80112 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-22 |
| Decision Date | 1990-03-06 |