Device Classification Name |
indicator, physical/chemical sterilization process
|
510(k) Number |
K122555 |
Device Name |
STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE |
Applicant |
STERITEC PRODUCTS MFG. CO., INC. |
74 INVERNESS DRIVE EAST |
ENGLEWOOD,
CO
80112
|
|
Applicant Contact |
JONATHAN RUTIGLIANO |
Correspondent |
STERITEC PRODUCTS MFG. CO., INC. |
74 INVERNESS DRIVE EAST |
ENGLEWOOD,
CO
80112
|
|
Correspondent Contact |
JONATHAN RUTIGLIANO |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 08/22/2012 |
Decision Date | 12/12/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|