The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Dantec Monopolar Lumen Electrode (13r18 And 13r19).
| Device ID | K950314 |
| 510k Number | K950314 |
| Device Name: | DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) |
| Classification | Electrode, Needle |
| 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 | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-26 |
| Decision Date | 1996-03-25 |