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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Eyelid Thermal Pulsation System
510(k) Number K133127
Device Name LIPIFLOW THERMAL PULSATION SYSTEM
Applicant
TEARSCIENCE, INC.
5151 MCCRIMMON PARKWAY
SUITE 250
MORRISVILLE,  NC  27560
Applicant Contact CHRISTY STEVENS, OD, MPH
Correspondent
TEARSCIENCE, INC.
5151 MCCRIMMON PARKWAY
SUITE 250
MORRISVILLE,  NC  27560
Correspondent Contact CHRISTY STEVENS, OD, MPH
Regulation Number886.5200
Classification Product Code
ORZ  
Date Received09/30/2013
Decision Date 12/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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