Device Classification Name |
Valve, Non-Rebreathing
|
510(k) Number |
K891124 |
Device Name |
NON-REBREATHING AIRWAY AND MASK(S) KITS |
Applicant |
AIRWAY PRODUCTS, INC. |
710 MAIN ST. - SUITE L |
BLUE SPRINGS,
MO
64015 -2934
|
|
Applicant Contact |
KEITH W SHEPARD |
Correspondent |
AIRWAY PRODUCTS, INC. |
710 MAIN ST. - SUITE L |
BLUE SPRINGS,
MO
64015 -2934
|
|
Correspondent Contact |
KEITH W SHEPARD |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 03/03/1989 |
Decision Date | 10/13/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|