MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM


Device Classification Name

plate, bone

510(k) Number K073307
Device Name MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM
Applicant
BIO-TECHNOLOGY USA, INC.
1705 s. capitol of texas hwy.
austin, 
TX 
78746

Applicant Contact ian gordon
Correspondent
BIO-TECHNOLOGY USA, INC.
1705 s. capitol of texas hwy.
austin, 
TX 
78746

Correspodent Contact ian gordon
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 11/23/2007
Decision Date 10/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No