FDA Registration
Active
🇺🇸 United States
Colonic Irrigator
Reg #: 1062839
·
FEI: 3000718678
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CLEARWATER COLON HYDROTHERAPY, INC.
- Registration Number
- 1062839
- FEI Number
- 3000718678
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3145 SW 74th Ter
- City
- OCALA
- State
- FL
- ZIP
- 34474
- Country
- US
Regulatory Submissions
- 510(k) Number
- K000388
Owner / Operator
- Firm Name
- CLEARWATER COLON HYDROTHERAPY, INC.
- Operator Number
- 9016062
- Address
- 3145 S.W. 74TH TERRACE, --
- City
- Ocala
- State
- FL
- Postal Code
- 34474
- Country
- US
- Correspondent
- MARY R BAKER
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Colonic Irrigation System | KPL | Class 2 | Gastroenterology, Urology | No | 2011-12-30 |
Proprietary Names
Colonic Irrigator
Establishment Types
Manufacture Medical Device