Device Classification Name |
labware, assisted reproduction
|
510(k) Number |
K112413 |
Device Name |
RI MSC (MIGRATION SEDIMENTATION CHAMBER) |
Applicant |
RESEARCH INSTRUMENTS LTD. |
BICKLAND INDUSTRIAL PARK |
FALMOUTH, CORNWALL,
GB
TR11 4TA
|
|
Applicant Contact |
DAVID LANSDOWNE |
Correspondent |
RESEARCH INSTRUMENTS LTD. |
BICKLAND INDUSTRIAL PARK |
FALMOUTH, CORNWALL,
GB
TR11 4TA
|
|
Correspondent Contact |
DAVID LANSDOWNE |
Regulation Number | 884.6160
|
Classification Product Code |
|
Date Received | 08/22/2011 |
Decision Date | 07/13/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|