The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Unipolar To Bipolar Pulse Gen. Adapter.
| Device ID | K802077 |
| 510k Number | K802077 |
| Device Name: | UNIPOLAR TO BIPOLAR PULSE GEN. ADAPTER |
| Classification | Pacemaker Lead Adaptor |
| Applicant | CARDIAC PACEMAKERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-28 |
| Decision Date | 1980-10-23 |