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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 K170527
Device Name Phoenix Clinical ICON
Applicant
Phoenix Technology Group, Inc. dba Phoenix Clinical
6630 Owens Drive
Pleasanton,  CA  94588
Applicant Contact Christopher A. Henderson
Correspondent
Phoenix Technology Group, Inc. dba Phoenix Clinical
6630 Owens Drive
Pleasanton,  CA  94588
Correspondent Contact Christopher A. Henderson
Regulation Number886.1120
Classification Product Code
HKI  
Date Received02/22/2017
Decision Date 09/15/2017
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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