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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 K813085
Device Name HEPAFIX BIOPSY NEEDLE SET
Applicant
Burron Medical Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Burron Medical Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.1075
Classification Product Code
KNW  
Date Received11/02/1981
Decision Date 11/20/1981
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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