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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 K151404
Device Name ProTrach Dualcare
Applicant
ATOS MEDICAL AB
KRAFTGATAN 8
HORBY,  SE SE-242 22
Applicant Contact Ferenc Dahner
Correspondent
ATOS MEDICAL AB
KRAFTGATAN 8
HORBY,  SE SE-242 22
Correspondent Contact Ferenc Dahner
Regulation Number868.5800
Classification Product Code
JOH  
Date Received05/26/2015
Decision Date 02/12/2016
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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