Device Classification Name |
wrap, sterilization
|
510(k) Number |
K140963 |
Device Name |
KIMGUARD SMART-FOLD STERILIZATION WRAP |
Applicant |
KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. |
ROSWELL,
GA
30076
|
|
Applicant Contact |
THOMAS KOZMA, PH.D. |
Correspondent |
KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. |
ROSWELL,
GA
30076
|
|
Correspondent Contact |
THOMAS KOZMA, PH.D. |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 04/15/2014 |
Decision Date | 11/10/2014 |
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
|
|
|