Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K113333 |
Device Name |
KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS |
Applicant |
KIMBERLY-CLARK CORPORATION |
1400 HOLCOMB BRIDGE RD. |
ROSWELL,
GA
30076
|
|
Applicant Contact |
MARCIA JOHNSON |
Correspondent |
KIMBERLY-CLARK CORPORATION |
1400 HOLCOMB BRIDGE RD. |
ROSWELL,
GA
30076
|
|
Correspondent Contact |
MARCIA JOHNSON |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 11/14/2011 |
Decision Date | 05/11/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|