FDA 510(k) Application Details - K973697

Device Classification Name	Lens, Contact (Orthokeratology)   More FDA Info for this Device
510(K) Number	K973697
Device Name	Lens, Contact (Orthokeratology)
Applicant	AIRPERM, INC. 4505 VAN NUYS BLVD. SHERMAN OAKS, CA 91403 US Other 510(k) Applications for this Company
Contact	NICK STOYAN 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	09/26/1997
Decision Date	04/08/1998
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