The following data is part of a premarket notification filed by Dantec Electronics, Inc. with the FDA for Sensory Needle Electrode Dne 111-115,116-117,118.
| Device ID | K894911 |
| 510k Number | K894911 |
| Device Name: | SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 |
| Classification | Electrode, Needle |
| 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 | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-01 |
| Decision Date | 1990-05-14 |