Device Classification Name |
tube, tracheostomy (w/wo connector)
|
510(k) Number |
K861645 |
Device Name |
MICRO-TRACHEOSTOMY CARE KIT |
Applicant |
ACI MEDICAL, INC. |
8835 MULBERRY DR. |
P.O. BOX 1134 |
SUNLAND,
CA
91040
|
|
Applicant Contact |
EDWARD J ARKANS |
Correspondent |
ACI MEDICAL, INC. |
8835 MULBERRY DR. |
P.O. BOX 1134 |
SUNLAND,
CA
91040
|
|
Correspondent Contact |
EDWARD J ARKANS |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 04/30/1986 |
Decision Date | 05/09/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|