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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Burr Hole
510(k) Number K001096
Device Name BURR HOLE COVER, MODEL XX
Applicant
IMAGE-GUIDED NEUROLOGICS, INC.
2290 EAU GALLIE BLVD.
MELBOURNE,  FL  32935
Applicant Contact DAVID M LEE
Correspondent
IMAGE-GUIDED NEUROLOGICS, INC.
2290 EAU GALLIE BLVD.
MELBOURNE,  FL  32935
Correspondent Contact DAVID M LEE
Regulation Number882.5250
Classification Product Code
GXR  
Date Received04/04/2000
Decision Date 10/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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