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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K181791
Device Name SIMPLYSTRONG, SIMPLYEZEE
Applicant
Genicon, Inc
6869 Stapoint Court
Suite 114
Winter Park,  FL  32792
Applicant Contact Katlyn Kachman
Correspondent
Genicon, Inc
6869 Stapoint Court
Suite 114
Winter Park,  FL  32792
Correspondent Contact Katlyn Kachman
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/05/2018
Decision Date 08/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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