ORTHO-WRAP BIORESORBABLE SHEET


Device Classification Name

mesh, surgical, polymeric

510(k) Number K072190
Device Name ORTHO-WRAP BIORESORBABLE SHEET
Applicant
MAST BIOSURGERY
6749 top gun street, suite 108
san diego, 
CA 
92121

Applicant Contact kenneth k kleinhenz
Correspondent
MAST BIOSURGERY
6749 top gun street, suite 108
san diego, 
CA 
92121

Correspodent Contact kenneth k kleinhenz
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 08/06/2007
Decision Date 01/16/2008
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