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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K914856
Device Name VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)
Applicant
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON,  IN  47402
Applicant Contact APRIL LAVENDER
Correspondent
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON,  IN  47402
Correspondent Contact APRIL LAVENDER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/29/1991
Decision Date 05/01/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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