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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K020854
Device Name MODIFICATION TO FOX PTA CATHETER
Applicant
Jomed AG
1700 Rockville Pike,Suite# 400
Rockville,  MD  20852
Applicant Contact CHRISTINA KICHULA
Correspondent
Jomed AG
1700 Rockville Pike,Suite# 400
Rockville,  MD  20852
Correspondent Contact CHRISTINA KICHULA
Regulation Number870.1250
Classification Product Code
LIT  
Date Received03/15/2002
Decision Date 04/11/2002
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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