Device Classification Name |
indicator, biological sterilization process
|
510(k) Number |
K854631 |
Device Name |
ASSERT EO BIOLOGICAL TEST PACK |
Applicant |
SURGICOT, INC. |
55 KENNEDY DR. |
SMITHTOWN,
NY
11787
|
|
Applicant Contact |
JAMES R BROWN |
Correspondent |
SURGICOT, INC. |
55 KENNEDY DR. |
SMITHTOWN,
NY
11787
|
|
Correspondent Contact |
JAMES R BROWN |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 11/18/1985 |
Decision Date | 05/27/1986 |
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
|
|
|