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FDA 510(k) Application Details - DEN100017
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN100017
Device Name
LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)
Applicant
TEARSCIENCE, INC.
1101 G AVIATION PKWY
MORRISVILLE, NC 27560 US
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Contact
CHRISTY MOENY
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Regulation Number
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Classification Product Code
ORZ
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More FDA Info for this Product Code
Date Received
08/09/2010
Decision Date
06/28/2011
Decision
DENG -
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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