ALACER SURGICAL SCAFFOLD


Device Classification Name

mesh, surgical, polymeric

510(k) Number K103445
Device Name ALACER SURGICAL SCAFFOLD
Applicant
ALACER BIOMEDICAL INC
200 boston avenue
suite 3700
medford, 
MA 
02155

Applicant Contact connie garrison
Correspondent
ALACER BIOMEDICAL INC
200 boston avenue
suite 3700
medford, 
MA 
02155

Correspodent Contact connie garrison
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 11/24/2010
Decision Date 02/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No