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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K970278
Device Name MICROVASIVE GOLD PROBE
Applicant
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK,  MA  01760 -1537
Applicant Contact LISA M QUAGLIA
Correspondent
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK,  MA  01760 -1537
Correspondent Contact LISA M QUAGLIA
Regulation Number876.4300
Classification Product Code
KNS  
Date Received01/23/1997
Decision Date 04/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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