The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Dantec Duet.
| Device ID | K960503 |
| 510k Number | K960503 |
| Device Name: | DANTEC DUET |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | DANTEC MEDICAL, INC. 3 PEARL CT. Allendale, NJ 07401 |
| Contact | Alan J Schaefer |
| Correspondent | Alan J Schaefer DANTEC MEDICAL, INC. 3 PEARL CT. Allendale, NJ 07401 |
| Product Code | FEN |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-02 |
| Decision Date | 1996-09-16 |
| Summary: | summary |