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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K022634
Device Name CO-AXIAL INTRODUCER 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 Number870.1340
Classification Product Code
DYB  
Date Received08/08/2002
Decision Date 11/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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