FDA 510(k) Application Details - K003855

Device Classification Name	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)   More FDA Info for this Device
510(K) Number	K003855
Device Name	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Applicant	FIDIA ADVANCED BIOPOLYMERS SRL VIA PONTE DELLA FABBRICA,3/A 35031 ABANO TERME (PD) 35031 IT Other 510(k) Applications for this Company
Contact	PAOLO RAMPAZZO 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	12/13/2000
Decision Date	07/03/2001
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