COLLAGEN TENDON WRAP


Device Classification Name

mesh, surgical

510(k) Number K080452
Device Name COLLAGEN TENDON WRAP
Applicant
COLLAGEN MATRIX, INC.
509 commerce st.
franklin lakes, 
NJ 
07417

Applicant Contact peggy hansen
Correspondent
COLLAGEN MATRIX, INC.
509 commerce st.
franklin lakes, 
NJ 
07417

Correspodent Contact peggy hansen
Regulation Number 878.3300
Classification Product Code
FTM  
Date Received 02/19/2008
Decision Date 05/15/2008
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