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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
Applicant
Smd Manufacturing, LLC
918 S 500 W, Suite A
Salt Lake City,  UT  84101
Applicant Contact Jared Spendlove
Correspondent
leanRAQA, LLC
131 E Loch Lomond Dr.
Oro Valley,  AZ  85737
Correspondent Contact Tianna Benson
Regulation Number868.5895
Classification Product Code
MNS  
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
Predetermined Change
Control Plan Authorized		 No
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