Device Classification Name |
gown, surgical
|
510(k) Number |
K080795 |
FOIA Releasable 510(k) |
K080795
|
Device Name |
ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN |
Applicant |
KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. |
BLDG 300, #1092 |
ROSWELL,
GA
30076 -2199
|
|
Applicant Contact |
DAVID M LEE |
Correspondent |
KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. |
BLDG 300, #1092 |
ROSWELL,
GA
30076 -2199
|
|
Correspondent Contact |
DAVID M LEE |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 03/20/2008 |
Decision Date | 09/03/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|