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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biopsy needle
510(k) Number K941722
Device Name FNA BIOPSY NEEDLE
Applicant
BETTA MEDICAL, INC.
547 WEST 9560
SOUTH SANDY,  UT  84070
Applicant Contact DONALD HOLBROOK
Correspondent
BETTA MEDICAL, INC.
547 WEST 9560
SOUTH SANDY,  UT  84070
Correspondent Contact DONALD HOLBROOK
Regulation Number876.1075
Classification Product Code
FCG  
Date Received04/07/1994
Decision Date 05/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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