FDA for Handpiece 510(K) Number: K192233. Regulation Number: 21 CFR 872.6070. 510(K) Number: K181691. Regulation Number: 872.4200. 510(K) Number: K163414. Regulation Number: 872.4850. The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies.
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