Device Classification Name |
Needle, Emergency Airway
|
510(k) Number |
K050166 |
Device Name |
PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT |
Applicant |
SMITHS MEDICAL |
MILITARY ROAD |
HYTHE, KENT,
GB
CT 21 5BN
|
|
Applicant Contact |
CHRISTOPHER TURNBULL |
Correspondent |
SMITHS MEDICAL |
MILITARY ROAD |
HYTHE, KENT,
GB
CT 21 5BN
|
|
Correspondent Contact |
CHRISTOPHER TURNBULL |
Regulation Number | 868.5090
|
Classification Product Code |
|
Date Received | 01/26/2005 |
Decision Date | 05/26/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|