Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K080821 |
Device Name |
MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE |
Applicant |
KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. |
ROSWELL,
GA
30076
|
|
Applicant Contact |
SHERRI SAURINI |
Correspondent |
KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. |
ROSWELL,
GA
30076
|
|
Correspondent Contact |
SHERRI SAURINI |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 03/24/2008 |
Decision Date | 04/22/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|