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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Battery-Powered
510(k) Number K123587
Device Name HEINE MINI 3000 LED OPHTHALMOSCOPE
Applicant
Heine Optotechnik GmbH & Co. KG
Kientalstrasse 7
Herrsching,  DE D-82211
Applicant Contact JOERG ROENNAU
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact OLAF TEICHERT
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received11/21/2012
Decision Date 03/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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