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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 K133597
Device Name CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
Applicant
COOK, INC.
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Applicant Contact SEAN SPENCE
Correspondent
COOK, INC.
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Correspondent Contact SEAN SPENCE
Regulation Number868.5800
Classification Product Code
JOH  
Date Received11/22/2013
Decision Date 04/18/2014
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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