DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE

DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE is an FDA 510(k)-cleared medical device (K945171) manufactured by Boston Surgical Products, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 7, 1995. Regulation: 8.