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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 K170598
Device Name ZeroWire Mobile
Applicant
Nds Surgical Imaging, LLC
5750 Hellyer Ave.
San Jose,  CA  95138
Applicant Contact Shala Famil
Correspondent
Rcq Consulting Services
1152 Navarro St.
Santa Rosa,  CA  95401
Correspondent Contact Shelley Trimm
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/01/2017
Decision Date 04/07/2017
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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