Device Classification Name |
Indicator, Biological Sterilization Process
|
510(k) Number |
K930682 |
Device Name |
EZTEST-STEAM |
Applicant |
SGM BIOTECH, INC. |
202 SOUTH BLACK |
BOZEMAN,
MT
59715
|
|
Applicant Contact |
JOHN R GILLIS |
Correspondent |
SGM BIOTECH, INC. |
202 SOUTH BLACK |
BOZEMAN,
MT
59715
|
|
Correspondent Contact |
JOHN R GILLIS |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 02/10/1993 |
Decision Date | 04/04/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|