The following data is part of a premarket notification filed by Consure Medical Pvt Ltd. with the FDA for Consure Stool Management System.
| Device ID | K133465 |
| 510k Number | K133465 |
| Device Name: | CONSURE STOOL MANAGEMENT SYSTEM |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | CONSURE MEDICAL PVT LTD. 11440 W. BERNARDO COURT, STE 300 San Diego, CA 92127 |
| Contact | Alan Donald |
| Correspondent | Alan Donald CONSURE MEDICAL PVT LTD. 11440 W. BERNARDO COURT, STE 300 San Diego, CA 92127 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-12 |
| Decision Date | 2014-06-26 |
| Summary: | summary |