SURGISIS GUIDED TISSUE REGENERATION MATRIX


Device Classification Name

barrier, animal source, intraoral

510(k) Number K010952
Device Name SURGISIS GUIDED TISSUE REGENERATION MATRIX
Original Applicant
COOK BIOTECH, INC.
3055 kent ave.
west lafayette, 
IN 
47906 -1076

Original Contact mark bleyer
Regulation Number 872.3930
Classification Product Code
NPL  
Date Received 03/30/2001
Decision Date 06/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No