The following data is part of a premarket notification filed by Clearwater Products, Llc with the FDA for The Water Lily.
| Device ID | K094022 |
| 510k Number | K094022 |
| Device Name: | THE WATER LILY |
| Classification | Colonic Irrigation System |
| Applicant | CLEARWATER PRODUCTS, LLC 1468 HARWELL AVE. Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith CLEARWATER PRODUCTS, LLC 1468 HARWELL AVE. Crofton, MD 21114 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-30 |
| Decision Date | 2010-06-11 |
| Summary: | summary |