Device Classification Name |
wrap, sterilization
|
510(k) Number |
K082177 |
Device Name |
KIMGUARD ONE-STEP STERILIZATION WRAP |
Applicant |
KIMBERLY-CLARK CORP. |
172 CONDUCTOR DRIVE |
DAWSONVILLE,
GA
30534
|
|
Applicant Contact |
LISA PEACOCK |
Correspondent |
KIMBERLY-CLARK CORP. |
172 CONDUCTOR DRIVE |
DAWSONVILLE,
GA
30534
|
|
Correspondent Contact |
LISA PEACOCK |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 08/01/2008 |
Decision Date | 03/27/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|