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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diagnostic Light, Soft Tissue Detector
510(k) Number K080043
Device Name VIZILITE EYEWEAR
Applicant
ZILA, INC.
5227 N. 7TH ST.
PHOENIX,  AZ  85014
Applicant Contact MARK BRIDE
Correspondent
ZILA, INC.
5227 N. 7TH ST.
PHOENIX,  AZ  85014
Correspondent Contact MARK BRIDE
Regulation Number872.6350
Classification Product Code
NXV  
Date Received01/08/2008
Decision Date 04/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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