AESCULAP NOVOSYN ABSORBABLE SUTURE


Device Classification Name

suture, absorbable, synthetic, polyglycolic acid

510(k) Number K122734
Device Name AESCULAP NOVOSYN ABSORBABLE SUTURE
Applicant
AESCULAP, INC.
3773 corporate parkway
center valley, 
PA 
18034

Applicant Contact kathy a racosky
Correspondent
AESCULAP, INC.
3773 corporate parkway
center valley, 
PA 
18034

Correspodent Contact kathy a racosky
Regulation Number 878.4493
Classification Product Code
GAM  
Date Received 09/06/2012
Decision Date 12/18/2012
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