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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 K861959
Device Name BMRI SOFT TISSUE BIOPSY NEEDLE
Applicant
Bio-Medical Resources, Inc.
11960 Westline Industrial Dr.
Suite 300
St. Louis County,  MO  63146
Applicant Contact ELI SCHACHET
Correspondent
Bio-Medical Resources, Inc.
11960 Westline Industrial Dr.
Suite 300
St. Louis County,  MO  63146
Correspondent Contact ELI SCHACHET
Regulation Number876.1075
Classification Product Code
KNW  
Date Received05/20/1986
Decision Date 09/23/1986
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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