The following data is part of a premarket notification filed by Poly-med, Inc. with the FDA for Europlate-conductive Adhesive Electrosurgical Retu.
| Device ID | K844780 |
| 510k Number | K844780 |
| Device Name: | EUROPLATE-CONDUCTIVE ADHESIVE ELECTROSURGICAL RETU |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | POLY-MED, INC. 109 INDUSTRY LN. Cockeysville, MD 21030 |
| Contact | Frank S Dinoto |
| Correspondent | Frank S Dinoto POLY-MED, INC. 109 INDUSTRY LN. Cockeysville, MD 21030 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-10 |
| Decision Date | 1985-05-21 |