The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Flexon Temporary Cardiac Pacer Lead.
| Device ID | K955722 |
| 510k Number | K955722 |
| Device Name: | FLEXON TEMPORARY CARDIAC PACER LEAD |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | DAVIS & GECK, INC. ONE CASPER ST. Danbury, CT 06810 |
| Contact | Stephen J Tamsett |
| Correspondent | Stephen J Tamsett DAVIS & GECK, INC. ONE CASPER ST. 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 | 1995-12-18 |
| Decision Date | 1996-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521103747 | K955722 | 000 |