Device Classification Name |
Sterilizer, Steam
|
510(k) Number |
K111736 |
Device Name |
TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES |
Applicant |
TUTTNAUER CO. LTD. |
1700 K STREET NW |
SUITE 300 |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
THEODORE SULLIVAN |
Correspondent |
TUTTNAUER CO. LTD. |
1700 K STREET NW |
SUITE 300 |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
THEODORE SULLIVAN |
Regulation Number | 880.6880
|
Classification Product Code |
|
Date Received | 06/20/2011 |
Decision Date | 12/08/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|