Device Classification Name |
Indicator, Physical/Chemical Sterilization Process
|
510(k) Number |
K103000 |
Device Name |
SMART READ BIOLOGICAL TEST PACK |
Applicant |
STERITEC PRODUCTS MFG. CO., INC. |
74 INVERNESS DRIVE EAST |
ENGLEWOOD,
CO
80112
|
|
Applicant Contact |
SUZANNE DENNIS |
Correspondent |
STERITEC PRODUCTS MFG. CO., INC. |
74 INVERNESS DRIVE EAST |
ENGLEWOOD,
CO
80112
|
|
Correspondent Contact |
SUZANNE DENNIS |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 10/08/2010 |
Decision Date | 02/11/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|