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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 K171827
Device Name ReddyPort NIV Access Elbow
Applicant
SMD Manufacturing, LLC
2500 South State Street, Suite D224
Salt Lake City,  UT  84115
Applicant Contact Rian Wendling
Correspondent
SMD Manufacturing, LLC
2500 South State Street, Suite D224
Salt Lake City,  UT  84115
Correspondent Contact Rian Wendling
Regulation Number868.5895
Classification Product Code
MNS  
Date Received06/20/2017
Decision Date 01/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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