Device Classification Name |
indicator, physical/chemical sterilization process
|
510(k) Number |
K761011 |
Device Name |
CASTLE TEC-TEST AERATION MONITOR |
Applicant |
CASTLE CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
CASTLE CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 11/09/1976 |
Decision Date | 12/02/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|