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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Illuminator, Non-Remote
510(k) Number K041621
Device Name LITEPORT LP100 SURGICAL ILLUMINATOR
Applicant
MEDICAL VISION INDUSTRIES, INC.
200 GREGORY LANE STE. C-100
PLEASANT HILL,  CA  94523 -3389
Applicant Contact DAVID SCHLERF
Correspondent
MEDICAL VISION INDUSTRIES, INC.
200 GREGORY LANE STE. C-100
PLEASANT HILL,  CA  94523 -3389
Correspondent Contact DAVID SCHLERF
Regulation Number878.4580
Classification Product Code
FTF  
Date Received06/16/2004
Decision Date 09/13/2004
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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