The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Generator, Pulse, Sorin Model Dl-1.
| Device ID | K780897 |
| 510k Number | K780897 |
| Device Name: | GENERATOR, PULSE, SORIN MODEL DL-1 |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | BENTLEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-01 |
| Decision Date | 1978-12-06 |