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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Components, Wheelchair
510(k) Number K870698
Device Name VAN-TEC PROSTATE BIOPSY NEEDLE
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 Number890.3920
Classification Product Code
KNN  
Date Received02/19/1987
Decision Date 03/25/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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