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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K191599
Device Name NICO Myriad NOVUS
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 Number878.4400
Classification Product Code
GEI  
Subsequent Product Codes
ERL   FST   HBC   HBI  
Date Received06/17/2019
Decision Date 09/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Obstetrics/Gynecology
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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