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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 K893553
Device Name BIPOLAR ELECTROSURGICAL SNARE
Applicant
Everest Medical Corp.
6601 Shingle Creek Pkwy.
Suite 400
Brooklyn Center,  MN  55430
Applicant Contact DAVID PARINS
Correspondent
Everest Medical Corp.
6601 Shingle Creek Pkwy.
Suite 400
Brooklyn Center,  MN  55430
Correspondent Contact DAVID PARINS
Regulation Number876.4300
Classification Product Code
FDI  
Date Received05/08/1989
Decision Date 09/08/1989
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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