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FDA 510(k) Application Details - K051477
Device Classification Name
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device
510(K) Number
K051477
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
MI GWANG CONTACT LENS CO., LTD.
2214 SANFORD DRIVE
B7
GRAND JUNCTION, CO 81505 US
Other 510(k) Applications for this Company
Contact
MARTIN DALSING
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
06/03/2005
Decision Date
03/10/2006
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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