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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tomography, optical coherence
510(k) Number K121993
Model 3300, 3600, 3100, 3400, 3200, 2100, 2400, 2000
Device Name SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT
Original Applicant
HEIDELBERG ENGINEERING GMBH
2995 steven martin dr.
fairfax,  VA  22031
Original Contact diane horwitz, ph.d.
Regulation Number886.1570
Classification Product Code
OBO  
Date Received07/09/2012
Decision Date 10/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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