BIOELAST 5-0 SUTURE, MODEL 500100


Device Classification Name

suture, recombinant technology

510(k) Number K072470
Device Name BIOELAST 5-0 SUTURE, MODEL 500100
Applicant
ENTRIGUE SURGICAL, INC.
3463 magic drive, suite 320
san antonio, 
TX 
78229

Applicant Contact gabriele niederauer
Correspondent
ENTRIGUE SURGICAL, INC.
3463 magic drive, suite 320
san antonio, 
TX 
78229

Correspodent Contact gabriele niederauer
Regulation Number 878.4494
Classification Product Code
NWJ  
Date Received 09/04/2007
Decision Date 11/16/2007
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