FDA 510(k) Application Details - K183200

Device Classification Name	Lens, Contact (Orthokeratology)   More FDA Info for this Device
510(K) Number	K183200
Device Name	Lens, Contact (Orthokeratology)
Applicant	C&E GP Specialist, Inc. 15970 Bernardo Center Drive, San Diego, CA 92127 US Other 510(k) Applications for this Company
Contact	Steve Wagner 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	11/19/2018
Decision Date	01/09/2019
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