Device Classification Name |
indicator, biological sterilization process
|
510(k) Number |
K091950 |
Device Name |
SMART-WELL EZTEST INCUBATOR |
Applicant |
SGM BIOTECH, INC. |
10 EVERGREEN DR. |
SUITE E |
BOZEMAN,
MT
59715
|
|
Applicant Contact |
JOHN R GILLIS |
Correspondent |
SGM BIOTECH, INC. |
10 EVERGREEN DR. |
SUITE E |
BOZEMAN,
MT
59715
|
|
Correspondent Contact |
JOHN R GILLIS |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 07/01/2009 |
Decision Date | 01/15/2010 |
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
|
|
|