
Hu-Friedy Mfg. Co., Inc.
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SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM is an FDA 510(k)-cleared medical device (K100401) manufactured by Hu-Friedy Mfg. Co., Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 29, 2010. Regulation: 8.