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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diagnostic Neurosurgical Microscope Filter
510(k) Number K232567
Device Name Myriad SPECTRA Light Source
Applicant
Nico Corporation
250 E 96th St. Suite 125
Indianapolis,  IN  46240
Applicant Contact Megan Becker
Correspondent
Nico Corporation
250 E 96th St. Suite 125
Indianapolis,  IN  46240
Correspondent Contact Megan Becker
Regulation Number882.4950
Classification Product Code
QFX  
Date Received08/24/2023
Decision Date 03/14/2024
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
Recalls CDRH Recalls
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