FDA 510(k) Application Details - K081001

Device Classification Name	Suture, Surgical, Absorbable, Polydioxanone   More FDA Info for this Device
510(K) Number	K081001
Device Name	Suture, Surgical, Absorbable, Polydioxanone
Applicant	SUTURES INDIA PVT., LTD. 472 D, 13TH CROSS, 4TH PHASE PEENYA INDUSTRIAL AREA BANGALORE 560058 IN Other 510(k) Applications for this Company
Contact	L.G. CHANDRASEKHAR 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	04/08/2008
Decision Date	06/09/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review