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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 K081130
Device Name BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER
Applicant
BRIDGEPOINT MEDICAL
8 SNOWBERRY COURT
ORINDA,  CA  94563
Applicant Contact MICHAEL A DANIEL
Correspondent
BRIDGEPOINT MEDICAL
8 SNOWBERRY COURT
ORINDA,  CA  94563
Correspondent Contact MICHAEL A DANIEL
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/21/2008
Decision Date 05/14/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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