FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER


Device Classification Name

instrument, manual, surgical, general use

510(k) Number K073664
Device Name FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER
Applicant
INJECTIMED, INC.
5616 mariola pl ne
albuquerque, 
NM 
87111

Applicant Contact richard g hunter
Correspondent
INJECTIMED, INC.
5616 mariola pl ne
albuquerque, 
NM 
87111

Correspodent Contact richard g hunter
Regulation Number 878.4800
Classification Product Code
MDM  
Date Received 12/26/2007
Decision Date 08/08/2008
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