The following data is part of a premarket notification filed by Neuromuscular Technologies, Inc. with the FDA for Dolotens Dental Tm 1.
| Device ID | K043373 |
| 510k Number | K043373 |
| Device Name: | DOLOTENS DENTAL TM 1 |
| Classification | Device, Muscle Monitoring |
| Applicant | NEUROMUSCULAR TECHNOLOGIES, INC. 17720 JEAN WAY #200 Lake Oswego, OR 97035 |
| Contact | Marie Jensen |
| Correspondent | Marie Jensen NEUROMUSCULAR TECHNOLOGIES, INC. 17720 JEAN WAY #200 Lake Oswego, OR 97035 |
| Product Code | KZM |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-08 |
| Decision Date | 2005-09-02 |
| Summary: | summary |