Device Classification Name |
sterilizer, steam
|
510(k) Number |
K112872 |
Device Name |
STATIM 2000 G4 CASSETTE |
Applicant |
SCICAN LTD. |
1440 DON MILLS RD. |
TORONTO, ONTARIO,
CA
M3B 3P9
|
|
Applicant Contact |
TERESA BOYCE |
Correspondent |
SCICAN LTD. |
1440 DON MILLS RD. |
TORONTO, ONTARIO,
CA
M3B 3P9
|
|
Correspondent Contact |
TERESA BOYCE |
Regulation Number | 880.6880
|
Classification Product Code |
|
Date Received | 09/30/2011 |
Decision Date | 07/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|