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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 K072148
Device Name CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
Applicant
COOK, INC.
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Applicant Contact SUSANNE GALIN
Correspondent
COOK, INC.
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Correspondent Contact SUSANNE GALIN
Regulation Number868.5800
Classification Product Code
JOH  
Date Received08/03/2007
Decision Date 10/03/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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