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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 K895868
Device Name HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE
Applicant
Baxter Healthcare Corp
7280 N. Caldwell
Niles,  IL  60648
Applicant Contact MATTHEW NOWLAND
Correspondent
Baxter Healthcare Corp
7280 N. Caldwell
Niles,  IL  60648
Correspondent Contact MATTHEW NOWLAND
Regulation Number882.4545
Classification Product Code
GYK  
Date Received10/04/1989
Decision Date 10/31/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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