REPLACEMENT BATTERIES PART NO. 5098,5135, 5097

REPLACEMENT BATTERIES PART NO. 5098,5135, 5097 is an FDA 510(k)-cleared medical device (K936018) manufactured by R & D Batteries, 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 February 21, 1994. Regulation: 8.