The following data is part of a premarket notification filed by Oscor Medical Corp. with the FDA for Temporary Pacemaker Electrode.
Device ID | K872972 |
510k Number | K872972 |
Device Name: | TEMPORARY PACEMAKER ELECTRODE |
Classification | Electrode, Pacemaker, Temporary |
Applicant | OSCOR MEDICAL CORP. 2311 US ALT. 19N. P.O. BOX 459 Palm Harbor, FL 33563 |
Contact | Brian K Cornish |
Correspondent | Brian K Cornish OSCOR MEDICAL CORP. 2311 US ALT. 19N. P.O. BOX 459 Palm Harbor, FL 33563 |
Product Code | LDF |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-29 |
Decision Date | 1987-12-03 |