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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K150722
Device Name EnFocus 2300, EnFocus 4400
Applicant
BIOPTIGEN, INC.
633 DAVIS DRIVE, SUITE 480
MORRISVILLE,  NC  27560
Applicant Contact Tammy B Carrea
Correspondent
BIOPTIGEN, INC.
633 DAVIS DRIVE, SUITE 480
MORRISVILLE,  NC  27562
Correspondent Contact Tammy B Carrea
Regulation Number886.1570
Classification Product Code
HLI  
Subsequent Product Code
OBO  
Date Received03/20/2015
Decision Date 12/02/2015
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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