The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Permanent Pacing Lead, Model Refino, Model: Refino-r, Ru, Rju.
| Device ID | K040569 |
| 510k Number | K040569 |
| Device Name: | PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU |
| Classification | Permanent Pacemaker Electrode |
| Applicant | Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Contact | Mila Doskocil |
| Correspondent | Mila Doskocil Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-04 |
| Decision Date | 2004-04-07 |