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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K031277
Device Name JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002
Applicant
Jomed, Inc.
2870 Kilgore Rd..
Rancho Cordova,,  CA  95670
Applicant Contact TERRY SCHULTZ
Correspondent
Jomed, Inc.
2870 Kilgore Rd..
Rancho Cordova,,  CA  95670
Correspondent Contact TERRY SCHULTZ
Regulation Number870.1330
Classification Product Code
DQX  
Date Received04/22/2003
Decision Date 05/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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