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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 K001132
Device Name BONE BIOPSY NEEDLE
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
KNW  
Date Received04/10/2000
Decision Date 05/01/2000
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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