GENUINE FIRST AID CPR MASK


Device Classification Name

valve, non-rebreathing

510(k) Number K112126
Device Name GENUINE FIRST AID CPR MASK
Applicant
GENUINE FIRST AID LLC
150 cherry lane rd.
east stroudsburg, 
PA 
18301

Applicant Contact gary lehnus
Correspondent
GENUINE FIRST AID LLC
150 cherry lane rd.
east stroudsburg, 
PA 
18301

Correspodent Contact gary lehnus
Regulation Number 868.5870
Classification Product Code
CBP  
Date Received 07/25/2011
Decision Date 12/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No