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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 K122481
FOIA Releasable 510(k) K122481
Device Name LIPIVIEW OCULAR SURFACE INTERFEROMETER
Applicant
TEARSCIENCE, INC.
5151 MCCRIMMON PKWY STE 250
Morrisville,  NC  27560
Applicant Contact CHRISTY STEVENS
Correspondent
TEARSCIENCE, INC.
5151 MCCRIMMON PKWY STE 250
Morrisville,  NC  27560
Correspondent Contact CHRISTY STEVENS
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Code
HJO  
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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