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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 K111488
Device Name MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
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 Number870.1330
Classification Product Code
DQX  
Date Received05/31/2011
Decision Date 06/30/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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