Device Classification Name |
cuff, tracheal tube, inflatable
|
510(k) Number |
K081805 |
Device Name |
CUFFALERT |
Applicant |
SUNMED |
24301 WOODSAGE DR. |
BONITA SPRINGS,
FL
34134 -2958
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
SUNMED |
24301 WOODSAGE DR. |
BONITA SPRINGS,
FL
34134 -2958
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.5750
|
Classification Product Code |
|
Date Received | 06/26/2008 |
Decision Date | 11/14/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|