FDA 510(k) Application Details - K981665

Device Classification Name	Topographer, Corneal, Ac-Powered   More FDA Info for this Device
510(K) Number	K981665
Device Name	Topographer, Corneal, Ac-Powered
Applicant	BIO-MEDICAL SCIENCES, INC. 101 TECHNOLOGY DR. BETHLEHEM, PA 18015 US Other 510(k) Applications for this Company
Contact	MARK E DILLON Other 510(k) Applications for this Contact
Regulation Number	886.1350   More FDA Info for this Regulation Number
Classification Product Code	MMQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/1998
Decision Date	12/07/1998
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