The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Coloplast Peristeen Anal Irrigation (pai) System.
| Device ID | K083770 |
| 510k Number | K083770 |
| Device Name: | COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | COLOPLAST A/S 1525 WEST RIVER ROAD Minneapolis, MN 55411 |
| Contact | Janell A Colley |
| Correspondent | Janell A Colley COLOPLAST A/S 1525 WEST RIVER ROAD 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 | 2008-12-18 |
| Decision Date | 2009-11-23 |
| Summary: | summary |