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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 K003159
Device Name CORDIS SLALOM PTA BALLOON CATHETER
Applicant
CORDIS CORP.
7 POWDER HORN DR.
WARREN,  NJ  07059
Applicant Contact CHUCK RYAN
Correspondent
CORDIS CORP.
7 POWDER HORN DR.
WARREN,  NJ  07059
Correspondent Contact CHUCK RYAN
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received10/10/2000
Decision Date 10/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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