The following data is part of a premarket notification filed by Contour Medical Technology, Inc. with the FDA for Disposable Hydrogel Defibrillation Electrode/pad.
| Device ID | K960329 |
| 510k Number | K960329 |
| Device Name: | DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | CONTOUR MEDICAL TECHNOLOGY, INC. 144 BAIN ST. Lavergne, TN 37086 |
| Contact | Josh Trantum |
| Correspondent | Josh Trantum CONTOUR MEDICAL TECHNOLOGY, INC. 144 BAIN ST. Lavergne, TN 37086 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-24 |
| Decision Date | 1996-07-02 |