MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT


Device Classification Name

valve, non-rebreathing

510(k) Number K081516
Device Name MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
Applicant
MEDSOURCE INTERNATIONAL, LLC.
5346 shoreline dr.
mound, 
MN 
55364

Regulation Number 868.5870
Classification Product Code
CBP  
Date Received 05/30/2008
Decision Date 08/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No