The following data is part of a premarket notification filed by Cardiac Control Systems, Inc. with the FDA for Bipolar Cardiac Pacemaker, Model 110.
| Device ID | K861009 |
| 510k Number | K861009 |
| Device Name: | BIPOLAR CARDIAC PACEMAKER, MODEL 110 |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | CARDIAC CONTROL SYSTEMS, INC. 3 COMMERCE BLVD. Palm Coast, FL 32164 |
| Contact | Kenneth J Durbin |
| Correspondent | Kenneth J Durbin CARDIAC CONTROL SYSTEMS, INC. 3 COMMERCE BLVD. Palm Coast, FL 32164 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-18 |
| Decision Date | 1986-04-23 |