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FDA 510(k) Application Details - K112704
Device Classification Name
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510(K) Number
K112704
Device Name
LIPIFLOW THERMAL PULSATION SYSTEM
Applicant
TEARSCIENCE, INC.
5151 MCCRIMMON PARKWAY
SUITE 250
MORRISVILLE, NC 27560 US
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Contact
CHRISTY STEVENS
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Regulation Number
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Classification Product Code
ORZ
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Date Received
09/16/2011
Decision Date
12/19/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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