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
|
|
Correspondent Contact |
Gary Lehnus |
Regulation Number | 868.5870
|
Classification Product Code |
|
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
|
|
|