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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 K994336
Device Name BITX PROBES
Applicant
Everest Medical Corp.
13755 First Ave., N.,
Suite 500
Minneapolis,  MN  55441
Applicant Contact FREDERICK G MADES
Correspondent
Everest Medical Corp.
13755 First Ave., N.,
Suite 500
Minneapolis,  MN  55441
Correspondent Contact FREDERICK G MADES
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/23/1999
Decision Date 02/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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