FDA 510(k) Application Details - K002629

Device Classification Name	Polymer, Ent Synthetic, Porous Polyethylene   More FDA Info for this Device
510(K) Number	K002629
Device Name	Polymer, Ent Synthetic, Porous Polyethylene
Applicant	PILLAR SURGICAL, INC. P.O. BOX 8141 LA JOLLA, CA 92038 US Other 510(k) Applications for this Company
Contact	ROB FRITZENKOTTER 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	08/23/2000
Decision Date	11/20/2000
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