Device Classification Name |
gown, surgical
|
510(k) Number |
K091357 |
Device Name |
MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 |
Applicant |
KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. |
ROSWELL,
GA
30076
|
|
Applicant Contact |
DAVID M LEE |
Correspondent |
KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. |
ROSWELL,
GA
30076
|
|
Correspondent Contact |
DAVID M LEE |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 05/08/2009 |
Decision Date | 08/10/2009 |
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
|
Recalls |
CDRH Recalls
|
|
|