Text Library Class II Colonic Irrigator CFR 21 876.5220 Classification Class I Enema Device CFR 21 876.5210 Classification Prescription Statement CFR 21 801.109 Directions for Use Speculum Testing NAMSA Abstract on Colon Hydrotherapy for Pre-endoscopy Preparation FDA Official Letter Questions & Response FAQ 2005 PVC/DHEP Free Inflow Tubing Testing Data Waste Hose Testing Data Danbury, CT Hospital: HYDROTHERAPY COMPAIRED WITH PEG-ES LAVAGE AND AQUEOUS SODIUM PHOSPHATE AS BOWEL PREPARATION FOR ELECTIVE COLONOSCOPY PART 807 — ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES Who must List, Register and Pay the Fee 807.20