Device Classification Name |
Indicator, Biological Sterilization Process
|
510(k) Number |
K113221 |
Device Name |
NAMSA BIOLOGICAL INDICATOR SPORE STRIPS |
Applicant |
NORTH AMERICAN SCIENCE ASSOC., INC. |
6750 WALES RD. |
NORTHWOOD,
OH
43619
|
|
Applicant Contact |
JULIE WHEELER |
Correspondent |
NORTH AMERICAN SCIENCE ASSOC., INC. |
6750 WALES RD. |
NORTHWOOD,
OH
43619
|
|
Correspondent Contact |
JULIE WHEELER |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 11/01/2011 |
Decision Date | 04/27/2012 |
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
|
|
|