FDA 510(k) Application Details - K970327

Device Classification Name	Shell, Scleral   More FDA Info for this Device
510(K) Number	K970327
Device Name	Shell, Scleral
Applicant	SOUTHWEST ARTIFICIAL EYES, INC. 4640 CENTERVIEW SAN ANTONIO, TX 78228 US Other 510(k) Applications for this Company
Contact	DANIEL M WENSKE Other 510(k) Applications for this Contact
Regulation Number	886.3800   More FDA Info for this Regulation Number
Classification Product Code	HQT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/28/1997
Decision Date	07/07/1997
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