The following data is part of a premarket notification filed by Lifeguard Medical Products, Inc. with the FDA for Monopolar Electrode.
| Device ID | K915296 |
| 510k Number | K915296 |
| Device Name: | MONOPOLAR ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LIFEGUARD MEDICAL PRODUCTS, INC. 400 LATHROP AVE. SUITE 200 River Forest, IL 60305 |
| Contact | Dourglas Hulfish |
| Correspondent | Dourglas Hulfish LIFEGUARD MEDICAL PRODUCTS, INC. 400 LATHROP AVE. SUITE 200 River Forest, IL 60305 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-15 |
| Decision Date | 1992-09-03 |