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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K941716
Device Name MICRODONTIC LENS
Applicant
New Image Industries, Inc.
620 Newport Center Dr.
Suite 575
Newport Beach,  CA  92660
Applicant Contact LEE HAND
Correspondent
New Image Industries, Inc.
620 Newport Center Dr.
Suite 575
Newport Beach,  CA  92660
Correspondent Contact LEE HAND
Regulation Number872.6640
Classification Product Code
EIA  
Date Received04/07/1994
Decision Date 08/10/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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