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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 K893992
Device Name NOETIX, BIOPSY NEEDLE
Applicant
Noetix, Inc.
5602 Elmwood Ave., Suite 122,
Elmwood Park
Indianapolis,  IN  46203
Applicant Contact JOSEPH MARK
Correspondent
Noetix, Inc.
5602 Elmwood Ave., Suite 122,
Elmwood Park
Indianapolis,  IN  46203
Correspondent Contact JOSEPH MARK
Regulation Number876.1075
Classification Product Code
KNW  
Date Received06/05/1989
Decision Date 09/08/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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