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