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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 K121745
Device Name MANTARAY GUIDEWIRES
Applicant
BRIDGEPOINT MEDICAL
13355 10TH AVE N,
SUITE #110
PLYMOUTH,  MN  55441
Applicant Contact JILL MUNSINGER
Correspondent
BRIDGEPOINT MEDICAL
13355 10TH AVE N,
SUITE #110
PLYMOUTH,  MN  55441
Correspondent Contact JILL MUNSINGER
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/14/2012
Decision Date 07/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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