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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
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