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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Device, Medical Examination, Ac Powered
510(k) Number K922278
Device Name ILLUMINATOR III
Applicant
Medical Illumination, Inc.
12734 Branford St.
Unit 1 & 2
Arleta,  CA  91331
Correspondent
Medical Illumination, Inc.
12734 Branford St.
Unit 1 & 2
Arleta,  CA  91331
Regulation Number880.6320
Classification Product Code
KZF  
Date Received05/15/1992
Decision Date 03/04/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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