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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name eyelid thermal pulsation system
De Novo Number DEN100017
510(K) Number K093937
Device Name LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)
Requester
tearscience, inc.
1101 g aviation pkwy
morrisville,  NC  27560
Contact christy moeny
Regulation Number886.5200
Classification Product Code
ORZ  
Date Received08/09/2010
Decision Date 06/28/2011
Decision granted (DENG)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
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