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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
Applicant
NICO CORPORATION
250 e 96th st ste 125
indianapolis,  IN  46240
Applicant Contact jay dittman
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 pfingsten rd.
northbrook,  IL  60062
Correspondent Contact ned devine
Regulation Number882.4800
Classification Product Code
GZT  
Subsequent Product Code
HRX  
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
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