The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Ethicon Temporary Cardiac Pacing Wire.
| Device ID | K822155 |
| 510k Number | K822155 |
| Device Name: | ETHICON TEMPORARY CARDIAC PACING WIRE |
| Classification | Stimulator, Bone Growth, Non-invasive |
| Applicant | ETHICON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LOF |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-23 |
| Decision Date | 1982-08-24 |