510(k) K002102
- Device
- GENTLE COLONICS IRRIGATION SYSTEM
- Applicant
- Gentle Colonics, Inc.
- 510(k) number
- K002102
- Product code
- KPL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-02-06
- Date received
- 2000-07-12
- Regulation
- 876.5220
- Classification name
- Colonic Irrigation System
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- GRACE HOLLAND
- Address
- 3722 Ave. Sausalito Irvine CA US 92606 92606
FDA Registration Numbers#
- 1223925
- 3043012240
- 2433012
- 1062839
- 1320894
- 1648139
- 9615415
- 3042228064
- 3005346382
- 3043012074
- 3022964615
- 3043011436
- 2027347
- 3007305485
Source Documents#
510(k) summary PDF not indicated by FDA
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| K000031 | AQUANET, MODEL EC 2000 | Prime Pacific Health Innovations Corporation | 2001-09-10 |
| K000388 | CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) | Clearwater Colon Hydrotherapy, Inc. | 2000-08-08 |
| K980868 | GC IRRIGATOR | Gentle Colonics, Inc. | 1998-08-06 |