TUTOPATCH


Device Classification Name

mesh, surgical

510(k) Number K991296
Device Name TUTOPATCH
Applicant
TUTOGEN MEDICAL U.S., INC.
13709 progress blvd.
box 19 south wing
alachua, 
FL 
32615

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

Correspodent Contact pj pardo
Regulation Number 878.3300
Classification Product Code
FTM  
Subsequent Product Codes
DXZ   OXH   PAJ  
Date Received 04/15/1999
Decision Date 10/06/2000
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