BONE FIXATION WIRE (KIRSCHNER WIRE)


Device Classification Name

pin, fixation, smooth

510(k) Number K073674
Device Name BONE FIXATION WIRE (KIRSCHNER WIRE)
Applicant
SIGNAL MEDICAL CORP.
400 pyramid dr.
marysville, 
MI 
48040

Applicant Contact louis a serafin
Correspondent
SIGNAL MEDICAL CORP.
400 pyramid dr.
marysville, 
MI 
48040

Correspodent Contact louis a serafin
Regulation Number 888.3040
Classification Product Code
HTY  
Date Received 12/28/2007
Decision Date 03/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No