
Bryggs Medical, LLC
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ULTepap Expiratory Positive Airway Pressure (EPAP) Device is an FDA 510(k)-cleared medical device (K191728) manufactured by Bryggs Medical, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 20, 2020. Regulation: 8.