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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, emergency, powered (resuscitator)
510(k) Number K173373
Device Name SafeT T-Piece Resuscitator
Applicant
Ventlab, LLC
2710 Northridge Drive NW - Suite A
Grand Rapids,  MI  49544
Applicant Contact Rob Yamashita
Correspondent
Ventlab, LLC
2710 Northridge Drive NW - Suite A
Grand Rapids,  MI  49544
Correspondent Contact Rob Yamashita
Regulation Number868.5925
Classification Product Code
BTL  
Date Received10/27/2017
Decision Date 11/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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