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FDA 510(k) Application Details - K021295
Device Classification Name
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device
510(K) Number
K021295
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
ST. SHINE OPTICAL CO., LTD.
13 RED FOX LN.
LITTLETON, CO 80127 US
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Contact
Kevin Walls
Other 510(k) Applications for this Contact
Regulation Number
886.5925
More FDA Info for this Regulation Number
Classification Product Code
LPL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/24/2002
Decision Date
06/04/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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