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FDA 510(k) Application Details - K011561
Device Classification Name
Accessories, Soft Lens Products
More FDA Info for this Device
510(K) Number
K011561
Device Name
Accessories, Soft Lens Products
Applicant
WILSA, INC.
2172 SOUTH JASON ST.
DENVER, CO 80223 US
Other 510(k) Applications for this Company
Contact
SALLY COOK
Other 510(k) Applications for this Contact
Regulation Number
886.5928
More FDA Info for this Regulation Number
Classification Product Code
LPN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/21/2001
Decision Date
11/20/2001
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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