CLEARWATER COLON HYDROTHERAPY MODEL PPC-101

Colonic Irrigation System

CLEARWATER COLON HYDROTHERAPY, INC.

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.

Pre-market Notification Details

• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B424400200	K942867	000
B424400151	K942867	000
B424400101	K942867	000