The following data is part of a premarket notification filed by Prosys International Ltd with the FDA for Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches.
| Device ID | K193325 |
| 510k Number | K193325 |
| Device Name: | Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ProSys International Ltd Suite 303, Highland House, 165 The Broadway Wimbledon, GB Sw19 1ne |
| Contact | Graham Steer |
| Correspondent | Graham Steer ProSys International Ltd Suite 303, Highland House, 165 The Broadway Wimbledon, GB Sw19 1ne |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-02 |
| Decision Date | 2020-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060182171556 | K193325 | 000 |
| 15060182171891 | K193325 | 000 |