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FDA 510(k) Application Details - K021907
Device Classification Name
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device
510(K) Number
K021907
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
IGEL VISION CARE PTE LTD.
201 KING ARTHUR COURT
TRACY, CA 95376 US
Other 510(k) Applications for this Company
Contact
DEBBIE MCINTIRE
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
06/10/2002
Decision Date
09/04/2002
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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