The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Peristeen Anal Irrigation System, Irrigation Accessory Unit, Irrigation Rectal Catheter, System Strap, Irrigation Tube.
| Device ID | K103254 |
| 510k Number | K103254 |
| Device Name: | PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis, MN 55411 |
| Contact | Brian Schmidt |
| Correspondent | Brian Schmidt COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis, MN 55411 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-03 |
| Decision Date | 2011-01-31 |
| Summary: | summary |