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FDA 510(k) Application Details - K090362
Device Classification Name
Case, Contact Lens
More FDA Info for this Device
510(K) Number
K090362
Device Name
Case, Contact Lens
Applicant
VOGUESTRAP
55 Northern Blvd
Suite 200
Great Neck, NY 11021 US
Other 510(k) Applications for this Company
Contact
MARIA F GRIFFIN
Other 510(k) Applications for this Contact
Regulation Number
886.5928
More FDA Info for this Regulation Number
Classification Product Code
LRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/13/2009
Decision Date
02/27/2009
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
Y
Expedited Review
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