The following data is part of a premarket notification filed by Innovamed Usa, Inc. with the FDA for Detrusan 500.
| Device ID | K994109 |
| 510k Number | K994109 |
| Device Name: | DETRUSAN 500 |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | INNOVAMED USA, INC. 1140 LEE BLVD., SUITE 101-103 Lehigh Acres, FL 33936 |
| Contact | E.h. Czadilek |
| Correspondent | E.h. Czadilek INNOVAMED USA, INC. 1140 LEE BLVD., SUITE 101-103 Lehigh Acres, FL 33936 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-06 |
| Decision Date | 2000-08-03 |
| Summary: | summary |