The following data is part of a premarket notification filed by Dantec Electronics, Inc. with the FDA for Concentric Electrode Type #13r01, 13r02.
| Device ID | K895460 |
| 510k Number | K895460 |
| Device Name: | CONCENTRIC ELECTRODE TYPE #13R01, 13R02 |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| Applicant | DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale, NJ 07401 |
| Contact | James T Quigley |
| Correspondent | James T Quigley DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale, NJ 07401 |
| Product Code | IKT |
| CFR Regulation Number | 890.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-06 |
| Decision Date | 1990-06-18 |