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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 Ln. Suite C-100
Pleasant Hill,  CA  94523
Applicant Contact DAVID SCHLERF
Correspondent
Medical Vision Industries, Inc.
200 Gregory Ln. Suite C-100
Pleasant Hill,  CA  94523
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
Predetermined Change
Control Plan Authorized		 No
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