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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Forceps, Biopsy, Electric
510(k) Number K904985
Device Name BIPOLAR BIOPSY FORCEPS
Applicant
EVEREST MEDICAL CORP.
13755 FIRST AVENUE NORTH
MINNEAPOLIS,  MN  55441
Applicant Contact DAVID J PARINS
Correspondent
EVEREST MEDICAL CORP.
13755 FIRST AVENUE NORTH
MINNEAPOLIS,  MN  55441
Correspondent Contact DAVID J PARINS
Regulation Number876.4300
Classification Product Code
KGE  
Date Received11/02/1990
Decision Date 01/25/1991
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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