DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0


Device Classification Name

suture, surgical, absorbable, polydioxanone

510(k) Number K080918
Device Name DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0
Applicant
Depuy Mitek
325 paramount drive
raynham, 
MA 
02767

Applicant Contact kristine christo
Correspondent
Depuy Mitek
325 paramount drive
raynham, 
MA 
02767

Correspodent Contact kristine christo
Regulation Number 878.4840
Classification Product Code
NEW  
Subsequent Product Code
GAT  
Date Received 04/01/2008
Decision Date 04/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No