FDA 510(k) Application Details - K010109

Device Classification Name	Lens, Contact (Orthokeratology)   More FDA Info for this Device
510(K) Number	K010109
Device Name	Lens, Contact (Orthokeratology)
Applicant	PARAGON VISION SCIENCES 947 EAST IMPALA AVE. MESA, AZ 85204 US Other 510(k) Applications for this Company
Contact	WILLIAM E MEYERS Other 510(k) Applications for this Contact
Regulation Number	886.5916   More FDA Info for this Regulation Number
Classification Product Code	MUW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/12/2001
Decision Date	02/28/2001
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review