The following data is part of a premarket notification filed by Dantec Electronics, Inc. with the FDA for 13l81 Disposable Sphincter Electrode, 13l33 Cable.
| Device ID | K874759 |
| 510k Number | K874759 |
| Device Name: | 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale, NJ 07401 |
| Contact | Henrik Henriksen |
| Correspondent | Henrik Henriksen DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale, NJ 07401 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-18 |
| Decision Date | 1988-04-14 |