Device Classification Name |
Needle, Emergency Airway
|
510(k) Number |
K010016 |
Device Name |
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER |
Applicant |
COOK, INC. |
925 SOUTH CURRY PIKE |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Applicant Contact |
LISA HOPKINS |
Correspondent |
COOK, INC. |
925 SOUTH CURRY PIKE |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Correspondent Contact |
LISA HOPKINS |
Regulation Number | 868.5090
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/02/2001 |
Decision Date | 10/09/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|