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 |