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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name retractor, self-retaining, for neurosurgery
510(k) Number K120691
Device Name BRAIN PORT
Original Applicant
250 e 96th st ste 125
indianapolis,  IN  46240
Original Contact jay dittman
Regulation Number882.4800
Classification Product Code
Subsequent Product Code
Date Received03/07/2012
Decision Date 06/05/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls