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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Analysis, Anterior Segment
510(k) Number K071183
Device Name ALLEGRO OCULYZER
Applicant
Wavelight AG
Am Wolfsmantel 5
Erlangen,  DE 91058
Applicant Contact ALEXANDER POPP
Correspondent
Wavelight AG
Am Wolfsmantel 5
Erlangen,  DE 91058
Correspondent Contact ALEXANDER POPP
Regulation Number886.1850
Classification Product Code
MXK  
Date Received04/30/2007
Decision Date 07/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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