ARTIGLASS L. O.R. GLASS SYRINGE


Device Classification Name

syringe, piston

510(k) Number K122416
Device Name ARTIGLASS L. O.R. GLASS SYRINGE
Applicant
ARTIGLASS SRL
via piemonte 13
due carrare padova, 

IT

35020

Applicant Contact federico baccarin
Correspondent
ARTIGLASS SRL
via piemonte 13
due carrare padova, 

IT

35020

Correspodent Contact federico baccarin
Regulation Number 880.5860
Classification Product Code
FMF  
Date Received 08/08/2012
Decision Date 05/03/2013
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