Device Classification Name |
accessory, assisted reproduction
|
510(k) Number |
K050197 |
Device Name |
MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 |
Applicant |
MINITUBE OF AMERICA, INC |
ONE EAST MAIN STREET, STE 300 |
MADISON,
WI
53703
|
|
Applicant Contact |
FREDERICK T RIKKERS |
Correspondent |
MINITUBE OF AMERICA, INC |
ONE EAST MAIN STREET, STE 300 |
MADISON,
WI
53703
|
|
Correspondent Contact |
FREDERICK T RIKKERS |
Regulation Number | 884.6120
|
Classification Product Code |
|
Date Received | 01/27/2005 |
Decision Date | 10/06/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|