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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 K093469
Device Name CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS
Applicant
Cook, Inc.
750 Daniels Way
Bloomington,  IN  47402 -0489
Applicant Contact SUSANNE GALIN
Correspondent
Cook, Inc.
750 Daniels Way
Bloomington,  IN  47402 -0489
Correspondent Contact SUSANNE GALIN
Regulation Number868.5800
Classification Product Code
JOH  
Date Received11/06/2009
Decision Date 01/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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