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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 K011270
Device Name AUTOMATED CORE BIOPSY DEVICE
Applicant
PROMEX, INC.
3049 HUDSON ST.
FRANKLIN,  IN  46131
Applicant Contact JOSEPH L MARK
Correspondent
PROMEX, INC.
3049 HUDSON ST.
FRANKLIN,  IN  46131
Correspondent Contact JOSEPH L MARK
Regulation Number876.1075
Classification Product Code
FCG  
Date Received04/26/2001
Decision Date 06/22/2001
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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