Device Classification Name |
gown, surgical
|
510(k) Number |
K052824 |
Device Name |
KIMBERLY-CLARK PROCEDURE GOWN |
Applicant |
KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. |
ROSWELL,
GA
30076
|
|
Applicant Contact |
CHERYL M SANZARE |
Correspondent |
KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. |
ROSWELL,
GA
30076
|
|
Correspondent Contact |
CHERYL M SANZARE |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 10/05/2005 |
Decision Date | 05/02/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|