FDA 510(k) Application Details - K974311

Device Classification Name	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)   More FDA Info for this Device
510(K) Number	K974311
Device Name	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Applicant	GYRUS ENT L.L.C. 2925 APPLING RD. BARTLETT, TN 38133 US Other 510(k) Applications for this Company
Contact	ALICIA FARAGE 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	11/17/1997
Decision Date	03/04/1998
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