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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 K971799
Device Name PRECISION FLOW OSV II
Applicant
Elekta Implants, SA
6011 Cellini St.
Coral Gables,  FL  33146
Applicant Contact BARBARA RAMSEYER
Correspondent
Elekta Implants, SA
6011 Cellini St.
Coral Gables,  FL  33146
Correspondent Contact BARBARA RAMSEYER
Regulation Number882.5550
Classification Product Code
JXG  
Date Received05/15/1997
Decision Date 02/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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