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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photorefractor
510(k) Number K934880
Device Name MTI PHOTOSCREENER
Applicant
Medical Technology and Innovations, Inc.
1710 Adams St.
Cedar Falls,  IA  50613
Applicant Contact JEREMY P FEAKINS
Correspondent
Medical Technology and Innovations, Inc.
1710 Adams St.
Cedar Falls,  IA  50613
Correspondent Contact JEREMY P FEAKINS
Regulation Number886.1120
Classification Product Code
MMF  
Date Received10/12/1993
Decision Date 04/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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