OSSTAPLE


Device Classification Name

staple, fixation, bone

510(k) Number K023203
Device Name OSSTAPLE
Original Applicant
BIOMEDICAL ENT., INC.
14785 omicron dr., suite 205
san antonio, 
TX 
78245

Original Contact w. casey fox
Regulation Number 888.3030
Classification Product Code
JDR  
Date Received 09/25/2002
Decision Date 10/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No