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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Ceiling Mounted
510(k) Number K132307
Device Name VIDA LED SURGICAL LIGHTING SYSTEM
Applicant
Convida Healthcare & Systems Corporation
2f And B2, #33, Dinghu Rd.
Guishan Township
Taoyuan County,  TW 33378
Applicant Contact RYAN HUNG
Correspondent
Convida Healthcare & Systems Corporation
2f And B2, #33, Dinghu Rd.
Guishan Township
Taoyuan County,  TW 33378
Correspondent Contact RYAN HUNG
Regulation Number878.4580
Classification Product Code
FSY  
Date Received07/24/2013
Decision Date 11/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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