FDA 510(k) Application Details - K083621

Device Classification Name	Polymer, Ent Synthetic, Porous Polyethylene   More FDA Info for this Device
510(K) Number	K083621
Device Name	Polymer, Ent Synthetic, Porous Polyethylene
Applicant	POREX SURGICAL, INC. 15 DART RD. NEWNAN, GA 30265 US Other 510(k) Applications for this Company
Contact	JERRI L MANN Other 510(k) Applications for this Contact
Regulation Number	874.3620   More FDA Info for this Regulation Number
Classification Product Code	JOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/2008
Decision Date	02/03/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review