The following data is part of a premarket notification filed by Consure Medical Pvt Ltd. with the FDA for Qora Aim Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit.
| Device ID | K153506 |
| 510k Number | K153506 |
| Device Name: | Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | CONSURE MEDICAL PVT LTD. 5L, THIRD FLOOR, SHAHPUR JAT New Delhi, IN 110049 |
| Contact | Nishith Chasmawala |
| Correspondent | Alan Donald MATRIX MEDICAL CONSULTING, INC. 8880 RIO SAN DIEGO DRIVE SUITE 800 San Diego, CA 92108 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-07 |
| Decision Date | 2016-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860974000358 | K153506 | 000 |
| 00860974000341 | K153506 | 000 |
| 00860974000334 | K153506 | 000 |