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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name perimeter, automatic, ac-powered
510(k) Number K092187
Device Name MAIA, MODEL 1
Applicant
CENTERVUE SPA
VIA TOMMASEO 77
PADOVA,  IT 35131
Applicant Contact GIULIANO BARBARO
Correspondent
CENTERVUE SPA
VIA TOMMASEO 77
PADOVA,  IT 35131
Correspondent Contact GIULIANO BARBARO
Regulation Number886.1605
Classification Product Code
HPT  
Subsequent Product Code
HLI  
Date Received07/21/2009
Decision Date 05/27/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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