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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 K970207
Device Name MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS
Applicant
BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Applicant Contact ANGELA RAUN
Correspondent
BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Correspondent Contact ANGELA RAUN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received01/21/1997
Decision Date 07/31/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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