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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 K760501
Device Name VALVE, STANDARD MODEL PUDENZE FLUSHING
Applicant
Heyer Schulte Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Heyer Schulte Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number882.5550
Classification Product Code
JXG  
Date Received08/23/1976
Decision Date 08/30/1976
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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