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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name biomicroscope, slit-lamp, ac-powered
510(k) Number K122481
Device Name LIPIVIEW OCULAR SURFACE INTERFEROMETER
Original Applicant
TEARSCIENCE, INC.
5151 mccrimmon pkwy ste 250
morrisville,  NC  27560
Original Contact christy stevens
Regulation Number886.1850
Classification Product Code
HJO  
Subsequent Product Code
HKI  
Date Received08/14/2012
Decision Date 12/31/2012
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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