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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 K052935
Device Name HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
Applicant
Heidelberg Engineering
Gerhart-Hauptmann-Strasse 30
Dossenheim,  DE 69221
Applicant Contact GERHARD ZINSER
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFFREY D RONGERO
Regulation Number886.1850
Classification Product Code
MXK  
Date Received10/19/2005
Decision Date 01/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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