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FDA 510(k) Application Details - K021248
Device Classification Name
Case, Contact Lens
More FDA Info for this Device
510(K) Number
K021248
Device Name
Case, Contact Lens
Applicant
IKEEPS, INC.
P.O. BOX 4341
CROFTON, MD 21114 US
Other 510(k) Applications for this Company
Contact
E. J. SMITH
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
04/19/2002
Decision Date
09/24/2002
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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