Device Classification Name |
Tube, Tracheostomy (W/Wo Connector)
|
510(k) Number |
K953559 |
Device Name |
LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION) |
Applicant |
SEIDEL MEDIZIN GMBH |
16 STOCKDORFER WEG |
BUCHENDORF,
DE
D-82131
|
|
Applicant Contact |
MARTHA STRASSER |
Correspondent |
SEIDEL MEDIZIN GMBH |
16 STOCKDORFER WEG |
BUCHENDORF,
DE
D-82131
|
|
Correspondent Contact |
MARTHA STRASSER |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 06/20/1995 |
Decision Date | 05/16/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|