The following data is part of a premarket notification filed by Oscor Medical Corp. with the FDA for Oscor Permanent Retractable Screw-in Pacing Lead Model Pr.
| Device ID | K964107 |
| 510k Number | K964107 |
| Device Name: | OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR |
| Classification | Permanent Pacemaker Electrode |
| Applicant | OSCOR MEDICAL CORP. 3816 DESOTO BLVD. P.O. BOX 459 Palm Harbor, FL 34683 |
| Contact | David M Lee |
| Correspondent | David M Lee OSCOR MEDICAL CORP. 3816 DESOTO BLVD. P.O. BOX 459 Palm Harbor, FL 34683 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Se Subject To Traking & Pms (PT) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-15 |
| Decision Date | 1997-04-01 |