REPLACE-A-TIP RECHARG. LOW TEMP.

REPLACE-A-TIP RECHARG. LOW TEMP. is an FDA 510(k)-cleared medical device (K841325) manufactured by Suncoast Medical Manufacturers, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 8, 1984. Regulation: 8.