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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 K870735
Device Name PROSTATIC ASPIRATION BIOPSY SET
Applicant
Van-Tec, Inc.
P.O. Box 26
Spencer,  IN  47460
Applicant Contact JAMES F VANCE
Correspondent
Van-Tec, Inc.
P.O. Box 26
Spencer,  IN  47460
Correspondent Contact JAMES F VANCE
Regulation Number876.1075
Classification Product Code
KNW  
Date Received02/25/1987
Decision Date 03/25/1987
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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