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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 K003920
Device Name CORDIS M3 PTA DILATATION CATHETER
Applicant
CORDIS CORP.
7 POWDER HORN DR.
warren,  NJ  07059
Applicant Contact charles (chuck) j ryan
Correspondent
CORDIS CORP.
7 POWDER HORN DR.
warren,  NJ  07059
Correspondent Contact charles (chuck) j ryan
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received12/19/2000
Decision Date 06/15/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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