The following data is part of a premarket notification filed by Specialty Health Products, Inc. with the FDA for Hydro-san Colonic Irrigation System.
| Device ID | K891585 |
| 510k Number | K891585 |
| Device Name: | HYDRO-SAN COLONIC IRRIGATION SYSTEM |
| Classification | Colonic Irrigation System |
| Applicant | SPECIALTY HEALTH PRODUCTS, INC. 21636 North 14th Ave Suite A-1 Phoenix, AZ 85027 |
| Contact | Deborah Solomon |
| Correspondent | Stephen Collins SPECIALTY HEALTH PRODUCTS, INC. 21636 N. 14TH AVE Suite A-1 Phoenix, AZ 85027 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-20 |
| Decision Date | 1989-08-03 |