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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube tracheostomy and tube cuff
510(k) Number K173912
Device Name BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube
Applicant
Smiths Medical ASD, Inc.
6000 Nathan Lane North
Minneapolis,  MN  55442
Applicant Contact Donna M. Semlak
Correspondent
Smiths Medical ASD, Inc.
6000 Nathan Lane North
Minneapolis,  MN  55442
Correspondent Contact Donna M. Semlak
Regulation Number868.5800
Classification Product Code
JOH  
Subsequent Product Code
BTO  
Date Received12/22/2017
Decision Date 05/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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