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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 K891022
Device Name INTRODUCER FOR PTCA GUIDING CATHETERS
Applicant
Argon Medical Corp.
1445 Flat Creek Rd.
P.O. Box 1970
Athens,  TX  75751
Applicant Contact CLAYTON KOON
Correspondent
Argon Medical Corp.
1445 Flat Creek Rd.
P.O. Box 1970
Athens,  TX  75751
Correspondent Contact CLAYTON KOON
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/28/1989
Decision Date 05/19/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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