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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 K112381
Device Name HI TORQUE CONNECT GUIDEWIRE
Applicant
LAKE REGION MEDICAL
LAKE REGION MED INTL R&D CTR
PARKMORE WEST BUSINESS
GALWAY,  IE EI
Applicant Contact KENNY WALSH
Correspondent
LAKE REGION MEDICAL
LAKE REGION MED INTL R&D CTR
PARKMORE WEST BUSINESS
GALWAY,  IE EI
Correspondent Contact KENNY WALSH
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/17/2011
Decision Date 11/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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