Device Classification Name |
Indicator, Biological Sterilization Process
|
510(k) Number |
K083665 |
Device Name |
VERIFY SCBI 275F 3-10 |
Applicant |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Applicant Contact |
JOHN ROBERT SCOVILLE, JR. |
Correspondent |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Correspondent Contact |
JOHN ROBERT SCOVILLE, JR. |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 12/10/2008 |
Decision Date | 09/01/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|