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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, NO.33, DINGHU RD
GUISHAN TOWNSHIP
TAOYUAN COUNTY,  TW 33378
Applicant Contact RYAN HUNG
Correspondent
CONVIDA HEALTHCARE & SYSTEMS CORPORATION
2F AND B2, NO.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
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