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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 K192300
Device Name EnlightenVue Microendoscopy System
Applicant
Enlightenvue, Inc.
1111 Race St.
Suite 6a
Denver,  CO  80206
Applicant Contact Giacomo Basadonna
Correspondent
Alira Health
1111 Race St.
Suite 6a
Denver,  CO  80206
Correspondent Contact Giacomo Basadonna
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/23/2019
Decision Date 03/20/2020
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
Predetermined Change
Control Plan Authorized		 No
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