The following data is part of a premarket notification filed by Colonplus Equipments & Speculums, S.l. with the FDA for Colonplus Colonkit Small, Colonplus Colonkit Large, Colonplus Colonkit With Stop Collar 6, Colonplus Colonkit With Stop Collar 10.
| Device ID | K152834 |
| 510k Number | K152834 |
| Device Name: | Colonplus Colonkit Small, Colonplus Colonkit Large, Colonplus Colonkit With Stop Collar 6, Colonplus Colonkit With Stop Collar 10 |
| Classification | Colonic Irrigation System |
| Applicant | COLONPLUS EQUIPMENTS & SPECULUMS, S.L. C/Portuetxe 13, 1 C 20018 San Sebastian (guipuzcoa), ES |
| Contact | Jorge Echevarria |
| Correspondent | Solmarie Velez Rivera Business Excellence Consulting, Inc. City View Plaza Suite #802/ #48 Road 165 Km 1.2 Guaynabo, PR 00968 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-29 |
| Decision Date | 2016-08-10 |
| Summary: | summary |