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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 K990205
Device Name DIGISCOPE OPHTHALMIC CAMERA
Applicant
EYE TEL IMAGING, INC.
15078 STILLFIELD PLACE
CENTREVILLE,  VA  20120
Applicant Contact KEVIN T QUINN
Correspondent
EYE TEL IMAGING, INC.
15078 STILLFIELD PLACE
CENTREVILLE,  VA  20120
Correspondent Contact KEVIN T QUINN
Regulation Number886.1120
Classification Product Code
HKI  
Date Received01/21/1999
Decision Date 03/26/1999
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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