Device Classification Name |
wrap, sterilization
|
510(k) Number |
K112300 |
Device Name |
KIMGUARD SMART-FOLD* STERILIZATION WRAP |
Applicant |
KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. |
BLDG 300 |
ROSWELL,
GA
30076 -2199
|
|
Applicant Contact |
Brenda Shelkey |
Correspondent |
KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. |
BLDG 300 |
ROSWELL,
GA
30076 -2199
|
|
Correspondent Contact |
Brenda Shelkey |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 08/10/2011 |
Decision Date | 01/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|