Device Classification Name |
Indicator, Physical/Chemical Sterilization Process
|
510(k) Number |
K052516 |
Device Name |
STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137 |
Applicant |
STERITEC PRODUCTS, INC. |
599 TOPEKA WAY, SUITE 400 |
CASTLE ROCK,
CO
80109
|
|
Applicant Contact |
LINDA NELSON |
Correspondent |
STERITEC PRODUCTS, INC. |
599 TOPEKA WAY, SUITE 400 |
CASTLE ROCK,
CO
80109
|
|
Correspondent Contact |
LINDA NELSON |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 09/14/2005 |
Decision Date | 10/03/2005 |
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
|
|
|