
Hans Rudolph, Inc.
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7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS is an FDA 510(k)-cleared medical device (K030822) manufactured by Hans Rudolph, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 2, 2003. Regulation: 8.