The following data is part of a premarket notification filed by Atlantic Health Group with the FDA for Hydro-clenz Unit.
| Device ID | K863539 |
| 510k Number | K863539 |
| Device Name: | HYDRO-CLENZ UNIT |
| Classification | Colonic Irrigation System |
| Applicant | ATLANTIC HEALTH GROUP 6400 ATLANTIC BLVD., SUITE 175 Norcross, GA 30071 |
| Contact | Roy Abell |
| Correspondent | Roy Abell ATLANTIC HEALTH GROUP 6400 ATLANTIC BLVD., SUITE 175 Norcross, GA 30071 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-11 |
| Decision Date | 1986-10-16 |