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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 K002970
Device Name SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901
Applicant
Medical Designs, LLC
213 Sunset Dr.
Brandon,  SD  57005
Applicant Contact PAUL JOHN AXT
Correspondent
Medical Designs, LLC
213 Sunset Dr.
Brandon,  SD  57005
Correspondent Contact PAUL JOHN AXT
Regulation Number882.5550
Classification Product Code
JXG  
Date Received09/22/2000
Decision Date 12/12/2000
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
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