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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 K190645
Device Name Arthrex NanoScope System
Applicant
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Applicant Contact Heli F. Chambi Infantas
Correspondent
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Correspondent Contact Heli F. Chambi Infantas
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/13/2019
Decision Date 07/05/2019
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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