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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 K961349
Device Name INJECTION GOLD PROBE
Applicant
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK,  MA  01760 -1537
Applicant Contact DANIEL J DILLON
Correspondent
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK,  MA  01760 -1537
Correspondent Contact DANIEL J DILLON
Regulation Number876.4300
Classification Product Code
KNS  
Date Received04/08/1996
Decision Date 05/15/1996
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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