Device Classification Name |
indicator, biological sterilization process
|
510(k) Number |
K093794 |
Device Name |
SMART-READ EZTEST-STEAM SCBI AND TEST PACK |
Applicant |
SGM BIOTECH, INC. |
10 EVERGREEN DR. |
SUITE E |
BOZEMAN,
MT
59715
|
|
Applicant Contact |
JOHN R GILLIS, PH.D. |
Correspondent |
SGM BIOTECH, INC. |
10 EVERGREEN DR. |
SUITE E |
BOZEMAN,
MT
59715
|
|
Correspondent Contact |
JOHN R GILLIS, PH.D. |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 12/10/2009 |
Decision Date | 05/14/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|