The following data is part of a premarket notification filed by Labeltape Meditect, Inc. with the FDA for Lmi Medical, Electrode, Electrosurgical, Disposable Dispersive Electrode With Cord.
| Device ID | K951328 |
| 510k Number | K951328 |
| Device Name: | LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids, MI 49508 |
| Contact | Marvin Snedeker |
| Correspondent | Marvin Snedeker LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids, MI 49508 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-23 |
| Decision Date | 1995-04-25 |