PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION

PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION is an FDA 510(k)-cleared medical device (K000265) manufactured by Primary Care Solutions, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 11, 2001. Regulation: 8.