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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K122937
Device Name SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)
Applicant
COOK, INC.
750 DANIELS WAY
Blmgtn,  IN  47404
Applicant Contact AMBER BROWN
Correspondent
COOK, INC.
750 DANIELS WAY
Blmgtn,  IN  47404
Correspondent Contact AMBER BROWN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received09/24/2012
Decision Date 12/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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