Device Classification Name |
Cuff, Tracheal Tube, Inflatable
|
510(k) Number |
K102704 |
Device Name |
EASY CUFF |
Applicant |
JOAN SPIEGEL, MD |
24301 |
WOODSTAGE DR. |
BONITA SPRINGS,
FL
34134
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
JOAN SPIEGEL, MD |
24301 |
WOODSTAGE DR. |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.5750
|
Classification Product Code |
|
Date Received | 09/20/2010 |
Decision Date | 03/10/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|