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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 K161228
Device Name Radiance Ultra Series ZeroWire Embedded
Applicant
Nds Surgical Imaging, LLC
5750 Hellyer Ave.
San Jose,  CA  95138
Applicant Contact Jim Leng
Correspondent
Nds Surgical Imaging, LLC
5750 Hellyer Ave.
San Jose,  CA  95138
Correspondent Contact Jim Leng
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/02/2016
Decision Date 05/26/2016
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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