FDA 510(k) Application Details - K080985

Device Classification Name	Suture, Surgical, Absorbable, Polydioxanone   More FDA Info for this Device
510(K) Number	K080985
Device Name	Suture, Surgical, Absorbable, Polydioxanone
Applicant	SURGICAL SPECIALTIES CORP. 13921 PARK CENTER RD. SUITE 200 HERNDON, VA 20171 US Other 510(k) Applications for this Company
Contact	TRUDY D ESTRIDGE Other 510(k) Applications for this Contact
Regulation Number	878.4840   More FDA Info for this Regulation Number
Classification Product Code	NEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/2008
Decision Date	04/23/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review