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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 K222890
Device Name RADIANCE ULTRA 32 4K ZEROWIRE DUO
Applicant
Nds Surgical Imaging, LLC
100 Paramount Dr., Suite 101
Sarasota,  FL  34232
Applicant Contact Jim Leng
Correspondent
Nds Surgical Imaging, LLC
100 Paramount Dr., Suite 101
Sarasota,  FL  34232
Correspondent Contact Jim Leng
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/23/2022
Decision Date 10/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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