The following data is part of a premarket notification filed by Biocare Intl. with the FDA for Bci-100 Fecal Incontinence System.
| Device ID | K904646 |
| 510k Number | K904646 |
| Device Name: | BCI-100 FECAL INCONTINENCE SYSTEM |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | BIOCARE INTL. 3375 PARK AVENUE, SUITE 2000A Wantagh, NY 11793 |
| Contact | Steven H Reichman |
| Correspondent | Steven H Reichman BIOCARE INTL. 3375 PARK AVENUE, SUITE 2000A Wantagh, NY 11793 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-11 |
| Decision Date | 1991-03-19 |