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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 K990907
Device Name REMOTE INTRODUCER, MODEL PI-1000
Applicant
IMAGE-GUIDED NEUROLOGICS, INC.
2290 EAU GALLIE BLVD.
MELBOURNE,  FL  32935
Applicant Contact MICHAEL J RENNER
Correspondent
IMAGE-GUIDED NEUROLOGICS, INC.
2290 EAU GALLIE BLVD.
MELBOURNE,  FL  32935
Correspondent Contact MICHAEL J RENNER
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/18/1999
Decision Date 08/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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