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