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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 K811288
Device Name SPETZLER LUMBAR-PERITONEAL SYSTEM
Applicant
AMERICAN HEYER SCHULTE
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN HEYER SCHULTE
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.5550
Classification Product Code
JXG  
Date Received05/11/1981
Decision Date 06/26/1981
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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