NEOTRACT ANCHOR SYSTEM


Device Classification Name

suture, nonabsorbable, synthetic, polyethylene

510(k) Number K073651
Device Name NEOTRACT ANCHOR SYSTEM
Applicant
NEOTRACT, INC.
4473 willow road
suite 100
pleasanton, 
CA 
94588

Applicant Contact suzan moser
Correspondent
NEOTRACT, INC.
4473 willow road
suite 100
pleasanton, 
CA 
94588

Correspodent Contact suzan moser
Regulation Number 878.5000
Classification Product Code
GAT  
Subsequent Product Code
GDW  
Date Received 12/26/2007
Decision Date 02/01/2008
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