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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 K904883
Device Name OPTYX
Applicant
Baxter Healthcare Corp
17221 Red Hill Ave.
P.O. Box 11150
Irvine,  CA  92614
Applicant Contact JACK P DOUGLAS
Correspondent
Baxter Healthcare Corp
17221 Red Hill Ave.
P.O. Box 11150
Irvine,  CA  92614
Correspondent Contact JACK P DOUGLAS
Regulation Number882.5550
Classification Product Code
JXG  
Date Received10/26/1990
Decision Date 07/24/1991
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
Recalls CDRH Recalls
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