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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 K080987
Device Name BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES
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 Received04/07/2008
Decision Date 02/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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