The following data is part of a premarket notification filed by Lifestream Purfication Systems, Llc. with the FDA for Angel Of Water Colon Hydrotherapy System.
| Device ID | K003720 |
| 510k Number | K003720 |
| Device Name: | ANGEL OF WATER COLON HYDROTHERAPY SYSTEM |
| Classification | Colonic Irrigation System |
| Applicant | LIFESTREAM PURFICATION SYSTEMS, LLC. 6401 MEADOWS WEST DR. Fort Worth, TX 76132 |
| Contact | Richard A Hamer |
| Correspondent | Amy H Bruno LIFESTREAM PURFICATION SYSTEMS, LLC. 7303 Burleson Rd., Ste 801 Austin, TX 78744 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-04 |
| Decision Date | 2002-06-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B149CM11 | K003720 | 000 |