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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 K003084
Device Name CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012
Applicant
Concentric Medical, Inc.
2585 Leghorn St.
Moutian View,  CA  94043
Applicant Contact LINDA BRADLEY
Correspondent
Concentric Medical, Inc.
2585 Leghorn St.
Moutian View,  CA  94043
Correspondent Contact LINDA BRADLEY
Regulation Number870.1330
Classification Product Code
DQX  
Date Received10/03/2000
Decision Date 05/16/2001
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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