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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 K831678
Device Name P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR
Applicant
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number882.5550
Classification Product Code
JXG  
Date Received05/23/1983
Decision Date 06/24/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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