FDA 510(k) Application Details - K033796

Device Classification Name	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)   More FDA Info for this Device
510(K) Number	K033796
Device Name	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Applicant	HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-I AMSTERDAM 1017 AP NL Other 510(k) Applications for this Company
Contact	ANGELIKA SCHERP 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	12/05/2003
Decision Date	01/30/2004
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