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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 K945146
Device Name CHIBA, FRANSEEN, WESTCOTT, SPINAL 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 Received10/20/1994
Decision Date 12/21/1994
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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