The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Deknatel Temporary Cardiac Pacing Wire.
Device ID | K873728 |
510k Number | K873728 |
Device Name: | DEKNATEL TEMPORARY CARDIAC PACING WIRE |
Classification | Electrode, Pacemaker, Temporary |
Applicant | DEKNATEL, INC. 2300 MARCUS AVE. Lake Success, NY 11042 |
Contact | Orofino |
Correspondent | Orofino DEKNATEL, INC. 2300 MARCUS AVE. Lake Success, NY 11042 |
Product Code | LDF |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-16 |
Decision Date | 1987-11-03 |