The following data is part of a premarket notification filed by Oscor Medical Corp. with the FDA for Modified Oscor Py Pacing Leads/modification.
| Device ID | K913158 |
| 510k Number | K913158 |
| Device Name: | MODIFIED OSCOR PY PACING LEADS/MODIFICATION |
| Classification | Permanent Pacemaker Electrode |
| Applicant | OSCOR MEDICAL CORP. 3816 DESOTO BLVD. P.O. BOX 459 Palm Harbor, FL 34683 |
| Contact | K Bowen-reynold |
| Correspondent | K Bowen-reynold 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 | 1991-07-08 |
| Decision Date | 1991-09-23 |