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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Snare, Flexible
510(k) Number K950496
Device Name SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
Applicant
Boston Scientific Corp
480 Pleasant St.
Watertown,  MA  02472
Applicant Contact Lorraine M Hanley
Correspondent
Boston Scientific Corp
480 Pleasant St.
Watertown,  MA  02472
Correspondent Contact Lorraine M Hanley
Regulation Number876.4300
Classification Product Code
FDI  
Date Received02/06/1995
Decision Date 03/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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