The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Disposable Monoplar Meddle Electrodes.
| Device ID | K915741 |
| 510k Number | K915741 |
| Device Name: | DISPOSABLE MONOPLAR MEDDLE ELECTRODES |
| Classification | Leukotome |
| Applicant | DANTEC MEDICAL, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Contact | Richard D Manthei |
| Correspondent | Richard D Manthei DANTEC MEDICAL, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Product Code | GXE |
| CFR Regulation Number | 882.4600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-20 |
| Decision Date | 1992-12-08 |