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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 K180034
Device Name Weinmann Tracheostomy Exchange Set
Applicant
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington,  IN  47404
Applicant Contact Paul Meyer
Correspondent
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington,  IN  47404
Correspondent Contact Paul Meyer
Regulation Number868.5800
Classification Product Code
JOH  
Date Received01/04/2018
Decision Date 05/07/2018
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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