The following data is part of a premarket notification filed by Sentry Medical Products, Inc. with the FDA for Sentry Disposable Dispersive Electrode.
| Device ID | K955636 |
| 510k Number | K955636 |
| Device Name: | SENTRY DISPOSABLE DISPERSIVE ELECTRODE |
| Classification | Electrode, Electrosurgical |
| Applicant | SENTRY MEDICAL PRODUCTS, INC. 331 S. EISENHOWER LN. Lombard, IL 60148 |
| Contact | Charles Ivers |
| Correspondent | Charles Ivers SENTRY MEDICAL PRODUCTS, INC. 331 S. EISENHOWER LN. Lombard, IL 60148 |
| Product Code | JOS |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-11 |
| Decision Date | 1996-03-27 |