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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 K892895
Device Name MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM
Applicant
Everest Medical Corp.
6601 Shingle Creek Pkwy.
Suite 400
Brooklyn Center,  MN  55430
Applicant Contact MICHAEL HOLLENHORST
Correspondent
Everest Medical Corp.
6601 Shingle Creek Pkwy.
Suite 400
Brooklyn Center,  MN  55430
Correspondent Contact MICHAEL HOLLENHORST
Regulation Number876.4300
Classification Product Code
KNS  
Date Received04/25/1989
Decision Date 09/25/1989
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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