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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 K101223
Device Name SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
Applicant
Heidelberg Engineering
1220 Nineteenth St., NW
Suite 300
Washington,  DC  20036
Applicant Contact DIANE MANDELL-HORWITZ
Correspondent
Heidelberg Engineering
1220 Nineteenth St., NW
Suite 300
Washington,  DC  20036
Correspondent Contact DIANE MANDELL-HORWITZ
Regulation Number886.1570
Classification Product Code
OBO  
Subsequent Product Code
MYC  
Date Received05/03/2010
Decision Date 10/01/2010
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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