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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K955265
Device Name CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETER
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact STEPHEN M ENOS
Correspondent
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact STEPHEN M ENOS
Regulation Number882.5550
Classification Product Code
JXG  
Date Received11/14/1995
Decision Date 12/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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