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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 K870981
Device Name MODEL 8700 BIPOLAR ELECTROSURGICAL GENERATOR
Applicant
Everest Medical Corp.
6601 Shingle Creek Pkwy.
Suite 400
Brooklyn Center,  MN  55430
Applicant Contact DWAYNE K BUCHHOLZ
Correspondent
Everest Medical Corp.
6601 Shingle Creek Pkwy.
Suite 400
Brooklyn Center,  MN  55430
Correspondent Contact DWAYNE K BUCHHOLZ
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/10/1987
Decision Date 05/06/1987
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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