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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Drill, Pneumatic
510(k) Number K000195
Device Name CRANIAL DRILL
Applicant
IMAGE-GUIDED NEUROLOGICS, INC.
2290 W. EAU GALLIE BLVD.
SUITE 210
MELBOURNE,  FL  32935
Applicant Contact DAVID M LEE
Correspondent
IMAGE-GUIDED NEUROLOGICS, INC.
2290 W. EAU GALLIE BLVD.
SUITE 210
MELBOURNE,  FL  32935
Correspondent Contact DAVID M LEE
Regulation Number882.4370
Classification Product Code
HBB  
Date Received01/21/2000
Decision Date 04/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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