FDA 510(k) Application Details - K971583

Device Classification Name	Ocular Peg   More FDA Info for this Device
510(K) Number	K971583
Device Name	Ocular Peg
Applicant	POREX TECHNOLOGIES CORP. 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	886.3320   More FDA Info for this Regulation Number
Classification Product Code	MQU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/1997
Decision Date	06/30/1997
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