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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 K990660
Device Name NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX
Applicant
Nmt Neurosciences Implants S.A.
6011 Cellini St.
Coral Gables,  FL  33146
Applicant Contact BARBARA RAMSEYER
Correspondent
Nmt Neurosciences Implants S.A.
6011 Cellini St.
Coral Gables,  FL  33146
Correspondent Contact BARBARA RAMSEYER
Regulation Number882.5550
Classification Product Code
JXG  
Date Received03/01/1999
Decision Date 09/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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