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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 K954155
Device Name GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE
Applicant
Promex, Inc.
1125 Brookside Ave.
Suite G500
Indianapolis,  IN  46202
Applicant Contact JOSEPH L MARK
Correspondent
Promex, Inc.
1125 Brookside Ave.
Suite G500
Indianapolis,  IN  46202
Correspondent Contact JOSEPH L MARK
Regulation Number876.1075
Classification Product Code
FCG  
Date Received09/05/1995
Decision Date 09/12/1995
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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