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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, shunt system implantation
510(k) Number K771529
Device Name PERITONEAL INTRODUCER & SHEATH
Applicant
CORDIS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CORDIS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.4545
Classification Product Code
GYK  
Date Received08/08/1977
Decision Date 08/16/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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