The following data is part of a premarket notification filed by Biotronik, Gmbh & Co. with the FDA for Label Change Unipolar Endocardial Lead, Djp 60-up.
| Device ID | K903929 |
| 510k Number | K903929 |
| Device Name: | LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP |
| Classification | Permanent Pacemaker Electrode |
| Applicant | BIOTRONIK, GMBH & CO. 6024 SOUTHWEST JEAN RD. UNIT B4 Lake Oswego, OR 97035 -5369 |
| Contact | Stout, Md |
| Correspondent | Stout, Md BIOTRONIK, GMBH & CO. 6024 SOUTHWEST JEAN RD. UNIT B4 Lake Oswego, OR 97035 -5369 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-20 |
| Decision Date | 1990-10-16 |