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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 K201252
Device Name Spectralis HRA+OCT and variants
Applicant
Heidelberg Engineering GmbH
Max-Jarecki-Strasse 8
Heidelberg,  DE 69115
Applicant Contact Christoph Schoess
Correspondent
Orasi Consulting, LLC
1655 Forest Dr.
Medina,  OH  44256
Correspondent Contact Lena Sattler
Regulation Number886.1570
Classification Product Code
OBO  
Subsequent Product Code
MYC  
Date Received05/11/2020
Decision Date 09/09/2020
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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