SPEMBLY 140 CRYOSYSTEM PROBES & TIPS

SPEMBLY 140 CRYOSYSTEM PROBES & TIPS is an FDA 510(k)-cleared medical device (K823835) manufactured by Keller Instruments, 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 January 16, 1983. Regulation: 8.