ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED)


Device Classification Name

suture, absorbable, synthetic, polyglycolic acid

510(k) Number K080412
Device Name ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED)
Applicant
SHANGHAI PUDONG JINHUAN MEDICAL PRODUCTS CO., LTD.
flemington ct
#155
la mirada, 
CA 
90638

Applicant Contact brandon choi
Correspondent
SHANGHAI PUDONG JINHUAN MEDICAL PRODUCTS CO., LTD.
flemington ct
#155
la mirada, 
CA 
90638

Correspodent Contact brandon choi
Regulation Number 878.4493
Classification Product Code
GAM  
Date Received 02/15/2008
Decision Date 09/04/2008
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