The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Flexon Temporary Cardiac Conductive Multifilament.
Device ID | K855139 |
510k Number | K855139 |
Device Name: | FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT |
Classification | Electrode, Pacemaker, Temporary |
Applicant | DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
Contact | Pellertier |
Correspondent | Pellertier DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
Product Code | LDF |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-23 |
Decision Date | 1986-02-26 |