FDA 510(k) Application Details - K032104

Device Classification Name	Conformer, Ophthalmic, Biological Tissue   More FDA Info for this Device
510(K) Number	K032104
Device Name	Conformer, Ophthalmic, Biological Tissue
Applicant	BIO-TISSUE, INC. 1301 K STREET, N.W. WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	DAVID J BLOCH Other 510(k) Applications for this Contact
Regulation Number	886.3130   More FDA Info for this Regulation Number
Classification Product Code	NQB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/08/2003
Decision Date	12/12/2003
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