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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 East 96th Street, Suite 125
Indianapolis,  IN  46240
Applicant Contact Sean Spence
Correspondent
NICO Corporation
250 East 96th Street, 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
Recalls CDRH Recalls
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