FDA 510(k) Application Details - K013243

Device Classification Name	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)   More FDA Info for this Device
510(K) Number	K013243
Device Name	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Applicant	BIOFORM, INC. 4133 COURTNEY ROAD, #10 FRANKSVILLE, WI 53126 US Other 510(k) Applications for this Company
Contact	VICTOR M BOWERS Other 510(k) Applications for this Contact
Regulation Number	874.3620   More FDA Info for this Regulation Number
Classification Product Code	KHJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2001
Decision Date	01/09/2002
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