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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
Device Name SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT
Applicant
HEIDELBERG ENGINEERING GMBH
2995 STEVEN MARTIN DR.
FAIRFAX,  VA  22031
Applicant Contact DIANE HORWITZ, PH.D.
Correspondent
HEIDELBERG ENGINEERING GMBH
2995 STEVEN MARTIN DR.
FAIRFAX,  VA  22031
Correspondent Contact DIANE HORWITZ, PH.D.
Regulation Number886.1570
Classification Product Code
OBO  
Date Received07/06/2012
Decision Date 10/25/2012
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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