
New Deantronics Taiwan , Ltd.
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DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB 312 PBH is an FDA 510(k)-cleared medical device (K982744) manufactured by New Deantronics Taiwan , Ltd.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 1998. Regulation: 8.