CLEARWATER COLON HYDROTHERAPY MODEL PPC-101
FDA 510(k) clearance K942867 · decided 1996-06-26
Clearance details
- K-number
- K942867
- Device name
- CLEARWATER COLON HYDROTHERAPY MODEL PPC-101
- Applicant
- Clearwater Colon Hydrotherapy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-06-17
- Decision date
- 1996-06-26
- Days to decision
- 740 days
- Clearance type
- Traditional
- Product code
- KPL
- Device class
- 2
- Regulation number
- 876.5220
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Clearwater, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Clearwater Colon Hydrotherapy
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.