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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(K) Number K971607
Device Name MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS
Applicant
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove,  MN  55311
Contact angela raun
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/01/1997
Decision Date 07/24/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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