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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 K896932
Device Name INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE
Applicant
THE WITMOORE GROUP, INC.
3702 EAST ROESER RD, STE
27,P.O.B.62404
PHOENIX,  AZ  85040 -3969
Applicant Contact GARY ALLSEBROOK
Correspondent
THE WITMOORE GROUP, INC.
3702 EAST ROESER RD, STE
27,P.O.B.62404
PHOENIX,  AZ  85040 -3969
Correspondent Contact GARY ALLSEBROOK
Regulation Number876.1075
Classification Product Code
FCG  
Date Received12/11/1989
Decision Date 06/22/1990
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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