The following data is part of a premarket notification filed by Winn Hirsch & Assoc. with the FDA for Electrode, Temporary Myocardial.
Device ID | K760513 |
510k Number | K760513 |
Device Name: | ELECTRODE, TEMPORARY MYOCARDIAL |
Classification | Permanent Pacemaker Electrode |
Applicant | WINN HIRSCH & ASSOC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTB |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-25 |
Decision Date | 1976-10-15 |