BAYERS BIMANUAL I/A HANDPIECES

BAYERS BIMANUAL I/A HANDPIECES is an FDA 510(k)-cleared medical device (K971064) manufactured by Visioncare Devices, 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 June 8, 1997. Regulation: 8.