FDA 510(k) Application Details - K012769

Device Classification Name	Polymer, Ear, Nose And Throat, Synthetic, Absorbable   More FDA Info for this Device
510(K) Number	K012769
Device Name	Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Applicant	MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	KENNETH K KLEINHENZ Other 510(k) Applications for this Contact
Regulation Number	874.3620   More FDA Info for this Regulation Number
Classification Product Code	NHB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2001
Decision Date	10/25/2001
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