The following data is part of a premarket notification filed by Gentle Colonics, Inc. with the FDA for Gc Irrigator.
| Device ID | K980868 |
| 510k Number | K980868 |
| Device Name: | GC IRRIGATOR |
| Classification | Colonic Irrigation System |
| Applicant | GENTLE COLONICS, INC. 3722 AVENUE SAUSALITO Irvine, CA 92606 -1849 |
| Contact | Karen U Salinas |
| Correspondent | Karen U Salinas GENTLE COLONICS, INC. 3722 AVENUE SAUSALITO Irvine, CA 92606 -1849 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-06 |
| Decision Date | 1998-08-06 |