XTRACT SYRINGE KEY SYSTEM


Device Classification Name

syringe, piston

510(k) Number K112475
Device Name XTRACT SYRINGE KEY SYSTEM
Applicant
XTRACT SOLUTIONS
9495 sw locust suite e
portland, 
OR 
97223

Applicant Contact keith lowrey
Correspondent
XTRACT SOLUTIONS
9495 sw locust suite e
portland, 
OR 
97223

Correspodent Contact keith lowrey
Regulation Number 880.5860
Classification Product Code
FMF  
Date Received 08/29/2011
Decision Date 11/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No