The following data is part of a premarket notification filed by Dotolo Research Corp. C/o Keller And Heckman with the FDA for Dotolo Colon Hydrotherapy Instrument.
| Device ID | K870534 |
| 510k Number | K870534 |
| Device Name: | DOTOLO COLON HYDROTHERAPY INSTRUMENT |
| Classification | Colonic Irrigation System |
| Applicant | DOTOLO RESEARCH CORP. C/O KELLER AND HECKMAN 1150 17TH STREET, N.W. SUITE 1000 Washington, DC 20036 |
| Contact | John S Eldred |
| Correspondent | John S Eldred DOTOLO RESEARCH CORP. C/O KELLER AND HECKMAN 1150 17TH STREET, N.W. SUITE 1000 Washington, DC 20036 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-09 |
| Decision Date | 1987-06-18 |