The following data is part of a premarket notification filed by Tridak Division Of Indicon, Inc. with the FDA for Nonimplanted Electrical Continence Device.
| Device ID | K891007 |
| 510k Number | K891007 |
| Device Name: | NONIMPLANTED ELECTRICAL CONTINENCE DEVICE |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | TRIDAK DIVISION OF INDICON, INC. 20 COMMERCE ST. UNIT 2 P.O. BOX 907 Williston, VT 05495 |
| Contact | Claude Regnier |
| Correspondent | Claude Regnier TRIDAK DIVISION OF INDICON, INC. 20 COMMERCE ST. UNIT 2 P.O. BOX 907 Williston, VT 05495 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-27 |
| Decision Date | 1990-06-07 |