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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 K891777
Device Name PRO-CUT BIOPSY NEEDLE
Applicant
TEKNAR, INC.
267 WOLFNER DR.
FENTON,  MO  63026 -2801
Applicant Contact JAMES D TAYLOR
Correspondent
TEKNAR, INC.
267 WOLFNER DR.
FENTON,  MO  63026 -2801
Correspondent Contact JAMES D TAYLOR
Regulation Number876.1075
Classification Product Code
FCG  
Date Received03/24/1989
Decision Date 05/04/1989
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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