FDA 510(k) Application Details - K972034

Device Classification Name	Conformer, Ophthalmic   More FDA Info for this Device
510(K) Number	K972034
Device Name	Conformer, Ophthalmic
Applicant	POREX SURGICAL, INC. 500 BOHANNON RD. FAIRBURN, GA 30213 US Other 510(k) Applications for this Company
Contact	HOWARD MERCER Other 510(k) Applications for this Contact
Regulation Number	886.3130   More FDA Info for this Regulation Number
Classification Product Code	HQN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/1997
Decision Date	01/20/1998
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