The following data is part of a premarket notification filed by Clearwater Colon Hydrotherapy, Inc. with the FDA for Clearwater Colon Hydrotherapy (disposable Speculum Spo1 Large & Sp02 Small).
| Device ID | K000388 |
| 510k Number | K000388 |
| Device Name: | CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) |
| Classification | Colonic Irrigation System |
| Applicant | CLEARWATER COLON HYDROTHERAPY, INC. 4451-A SOUTH PINE AVE. Ocala, FL 34480 |
| Contact | Stuart K Baker |
| Correspondent | Stuart K Baker CLEARWATER COLON HYDROTHERAPY, INC. 4451-A SOUTH PINE AVE. Ocala, FL 34480 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-07 |
| Decision Date | 2000-08-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B424924448 | K000388 | 000 |
| B424720200 | K000388 | 000 |
| B424720300 | K000388 | 000 |
| B424720400 | K000388 | 000 |
| B424921442 | K000388 | 000 |
| B424921448 | K000388 | 000 |
| B424922442 | K000388 | 000 |
| B424922448 | K000388 | 000 |
| B424923442 | K000388 | 000 |
| B424923448 | K000388 | 000 |
| B424924442 | K000388 | 000 |
| B424720100 | K000388 | 000 |