FDA 510(k) Application Details - K013110

Device Classification Name	Haploscope   More FDA Info for this Device
510(K) Number	K013110
Device Name	Haploscope
Applicant	OPTICAL DIAGNOSTICS, INC. 490 MT. FURY CIRCLE SW ISSAQUAH, WA 98027 US Other 510(k) Applications for this Company
Contact	JOYCE DE WIT Other 510(k) Applications for this Contact
Regulation Number	886.1340   More FDA Info for this Regulation Number
Classification Product Code	HJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2001
Decision Date	12/19/2001
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