Device Classification Name |
sterilizer, steam
|
510(k) Number |
K090670 |
Device Name |
MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER |
Applicant |
MIDMARK CORP. |
60 VISTA DR. |
P.O. BOX 286 |
VERSAILLES,
OH
45380
|
|
Applicant Contact |
GARY BENNING |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
JAY Y KOGOMA |
Regulation Number | 880.6880
|
Classification Product Code |
|
Date Received | 03/13/2009 |
Decision Date | 07/07/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|