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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 K100195
Device Name NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X
Applicant
Nds Surgical Imaging
5750 Hellyer Ave.
San Jose,  CA  95138
Applicant Contact JIM LENG
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/22/2010
Decision Date 04/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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