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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, continuous, non-life-supporting
510(k) Number K231064
Device Name ReddyPort Elbow
SMD Manufacturing LLC
918 S 500 W, Ste A
Salt Lake City,  UT  84101
Applicant Contact Jared Spendlove
131 E Loch Lomond Dr.
Oro Valley,  AZ  85737
Correspondent Contact Tianna Benson
Regulation Number868.5895
Classification Product Code
Date Received04/14/2023
Decision Date 07/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No