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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 K010400
Device Name VACUUM ASSISTED CORE BIOPSY DEVICE
Applicant
Promex, Inc.
3049 Hudson St.
P.O. Box 787
Franklin,  IN  46131
Applicant Contact JOSEPH L MARK
Correspondent
Promex, Inc.
3049 Hudson St.
P.O. Box 787
Franklin,  IN  46131
Correspondent Contact JOSEPH L MARK
Regulation Number876.1075
Classification Product Code
KNW  
Date Received02/12/2001
Decision Date 07/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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