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FDA 510(k) Application Details - K192623
Device Classification Name
More FDA Info for this Device
510(K) Number
K192623
Device Name
LipiFlow Thermal Pulsation System
Applicant
TearScience Inc.
1700 East St. Andrew Place
Santa Ana, CA 92705 US
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Contact
Michelle Ricafort
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
ORZ
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More FDA Info for this Product Code
Date Received
09/23/2019
Decision Date
10/22/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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