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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K895841
Device Name MODEL 8750 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENE.
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 Number878.4400
Classification Product Code
GEI  
Date Received10/02/1989
Decision Date 11/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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