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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 K150378
Device Name NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
Applicant
NICO Corporation
250 E 96TH ST Suite 125
Indianapolis,  IN  46240
Applicant Contact Sean Spence
Correspondent
NICO Corporation
250 E 96TH ST Suite 125
Indianapolis,  IN  46240
Correspondent Contact Sean Spence
Regulation Number882.4800
Classification Product Code
GZT  
Date Received02/13/2015
Decision Date 06/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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