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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K031732
Device Name EBI ACUMEN SURGICAL NAVIGATION SYSTEM
Applicant
Ebi, L.P.
399 Jefferson Rd.
Parsippany,  NJ  07054
Applicant Contact JON CAPAROTTA
Correspondent
Ebi, L.P.
399 Jefferson Rd.
Parsippany,  NJ  07054
Correspondent Contact JON CAPAROTTA
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/04/2003
Decision Date 10/15/2003
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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