PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE


Device Classification Name

suture, surgical, absorbable, polydioxanone

510(k) Number K081001
Device Name PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE
Applicant
SUTURES INDIA PVT., LTD.
472 d, 13th cross, 4th phase
peenya industrial area
bangalore, 

IN

560058

Applicant Contact l.g. chandrasekhar
Correspondent
SUTURES INDIA PVT., LTD.
472 d, 13th cross, 4th phase
peenya industrial area
bangalore, 

IN

560058

Correspodent Contact l.g. chandrasekhar
Regulation Number 878.4840
Classification Product Code
NEW  
Date Received 04/08/2008
Decision Date 06/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No