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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
Original Applicant
BRIDGEPOINT MEDICAL
13355 10th ave n,
suite #110
plymouth,  MN  55441
Original 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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