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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K973950
Device Name RETINAL CUBE
Applicant
APPLIED SPECTRAL IMAGING, LTD.
P.O. BOX 101
MIGDAL HAEMEK,  IL 10551
Applicant Contact MICHAEL ADEL
Correspondent
APPLIED SPECTRAL IMAGING, LTD.
P.O. BOX 101
MIGDAL HAEMEK,  IL 10551
Correspondent Contact MICHAEL ADEL
Regulation Number886.1120
Classification Product Code
HKI  
Date Received10/16/1997
Decision Date 12/12/1997
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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