Device Classification Name |
Wrap, Sterilization
|
510(k) Number |
K122507 |
Device Name |
DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION |
Applicant |
CARDINAL HEALTH 200, LLC |
1430 WAUKEGAN ROAD |
WAUKEGAN,
IL
60085
|
|
Applicant Contact |
LAVENIA FORD |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 08/17/2012 |
Decision Date | 09/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|