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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K111963
Device Name BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER
Applicant
Bridgepoint Medical
2800 Campus Dr.
Suite 50
Plymouth,  MN  55441
Applicant Contact JILL MUNSINGER
Correspondent
Bridgepoint Medical
2800 Campus Dr.
Suite 50
Plymouth,  MN  55441
Correspondent Contact JILL MUNSINGER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/11/2011
Decision Date 08/10/2011
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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