OSSTAPLE, MAXILLOFACIAL


Device Classification Name

plate, bone

510(k) Number K023486
Device Name OSSTAPLE, MAXILLOFACIAL
Original Applicant
BIOMEDICAL ENTERPRISES, INC
14785 omicron dr ste 205
san antonio, 
TX 
78245

Original Contact w. casey fox
Regulation Number 872.4760
Classification Product Code
JEY  
Subsequent Product Code
HRS  
Date Received 10/17/2002
Decision Date 10/31/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No