The following data is part of a premarket notification filed by Clearwater Colon Hydrotherapy, Inc. with the FDA for Clearwater Colon Hydrotherapy Model Ppc-101.
Device ID | K942867 |
510k Number | K942867 |
Device Name: | CLEARWATER COLON HYDROTHERAPY MODEL PPC-101 |
Classification | Colonic Irrigation System |
Applicant | CLEARWATER COLON HYDROTHERAPY, INC. 3130 THOMAS RD. Clearwater, FL 34619 |
Contact | Mary Ruth Baker |
Correspondent | Mary Ruth Baker CLEARWATER COLON HYDROTHERAPY, INC. 3130 THOMAS RD. Clearwater, FL 34619 |
Product Code | KPL |
CFR Regulation Number | 876.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-17 |
Decision Date | 1996-06-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B424400200 | K942867 | 000 |
B424400151 | K942867 | 000 |
B424400101 | K942867 | 000 |