The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Dantec Menuet.
| Device ID | K896575 |
| 510k Number | K896575 |
| Device Name: | DANTEC MENUET |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | DANTEC MEDICAL, INC. 777 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | James T Quigley |
| Correspondent | James T Quigley DANTEC MEDICAL, INC. 777 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-20 |
| Decision Date | 1990-05-03 |