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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K930479
Device Name NYLEX CATHETERS
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact TYE R MINNICK
Correspondent
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact TYE R MINNICK
Regulation Number870.1200
Classification Product Code
DQO  
Date Received01/29/1993
Decision Date 04/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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