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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K880722
Device Name COATING FOR WIRE GUIDE
Applicant
Cook, Inc.
925 S. Curry Pike
P.O. Box 489
Bloomington,  IN  47402
Applicant Contact APRIL LAVENDER
Correspondent
Cook, Inc.
925 S. Curry Pike
P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact APRIL LAVENDER
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/23/1988
Decision Date 08/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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