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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 K083323
Device Name NUVO VERDE LED LIGHTING SYSTEM
Applicant
NUVO, INC.
5368 KUHL RD.
ERIE,  PA  16407
Applicant Contact CURT V SCHAAFF
Correspondent
NUVO, INC.
5368 KUHL RD.
ERIE,  PA  16407
Correspondent Contact CURT V SCHAAFF
Regulation Number878.4580
Classification Product Code
FSY  
Date Received11/12/2008
Decision Date 01/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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