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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K021088
Device Name JOGUIDE CARDIOVASCULAR GUIDING C ATHETER
Applicant
Jomed Catheter, Inc.
604 Queensbury Ave.
Queensbury,  NY  12804
Applicant Contact NORMAN L HALL
Correspondent
Jomed Catheter, Inc.
604 Queensbury Ave.
Queensbury,  NY  12804
Correspondent Contact NORMAN L HALL
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/04/2002
Decision Date 05/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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