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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K914215
Device Name SELECTACUT BIOPSY DEVICE
Applicant
Biomni Medical Systems, Inc.
130 W. Center
Alpine,  UT  84004
Applicant Contact LAVON BENNETT
Correspondent
Biomni Medical Systems, Inc.
130 W. Center
Alpine,  UT  84004
Correspondent Contact LAVON BENNETT
Regulation Number876.1075
Classification Product Code
KNW  
Date Received09/19/1991
Decision Date 02/24/1992
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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