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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 K896933
Device Name INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE GUN
Applicant
The Witmoore Group, Inc.
3702 E. Roeser Rd., Suite
27,P.O.B.62404
Phoenix,  AZ  85040
Applicant Contact GARY ALLSEBROOK
Correspondent
The Witmoore Group, Inc.
3702 E. Roeser Rd., Suite
27,P.O.B.62404
Phoenix,  AZ  85040
Correspondent Contact GARY ALLSEBROOK
Regulation Number876.1075
Classification Product Code
KNW  
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
Predetermined Change
Control Plan Authorized		 No
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