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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
Predetermined Change
Control Plan Authorized		 No
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