TUTODENT DENTAL MEMBRANE


Device Classification Name

barrier, animal source, intraoral

510(k) Number K073097
Device Name TUTODENT DENTAL MEMBRANE
Applicant
TUTOGEN MEDICAL U.S., INC.
13709 progress blvd.
box 19 south wing
alachua, 
FL 
32615

Applicant Contact travis arola
Correspondent
TUTOGEN MEDICAL U.S., INC.
13709 progress blvd.
box 19 south wing
alachua, 
FL 
32615

Correspodent Contact travis arola
Regulation Number 872.3930
Classification Product Code
NPL  
Date Received 11/01/2007
Decision Date 05/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No