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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 K091328
Device Name SIPHONX GRAVITATIONAL ANTISIPHON DEVICE
Applicant
Sophysa SA
8502 E. Chapman Ave.
Suite 234
Orange,  CA  92869
Applicant Contact GUSTAVO KOBRIN
Correspondent
Sophysa SA
8502 E. Chapman Ave.
Suite 234
Orange,  CA  92869
Correspondent Contact GUSTAVO KOBRIN
Regulation Number882.5550
Classification Product Code
JXG  
Date Received05/05/2009
Decision Date 01/22/2010
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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