The following data is part of a premarket notification filed by Oscor Medical Corp. with the FDA for Permanent Pacing Leads Pybj Series.
| Device ID | K882345 |
| 510k Number | K882345 |
| Device Name: | PERMANENT PACING LEADS PYBJ SERIES |
| Classification | Permanent Pacemaker Electrode |
| Applicant | OSCOR MEDICAL CORP. 3816 DESOTO BLVD. P.O. BOX 459 Palm Harbor, FL 34683 |
| Contact | De Graad |
| Correspondent | De Graad OSCOR MEDICAL CORP. 3816 DESOTO BLVD. P.O. BOX 459 Palm Harbor, FL 34683 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-07 |
| Decision Date | 1988-10-28 |