Device Classification Name |
microtools, assisted reproduction (pipettes)
|
510(k) Number |
K161275 |
Device Name |
EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip |
Applicant |
RESEARCH INSTRUMENTS LIMITED |
BICKLAND INDUSTRIAL PARK |
FALMOUTH,
GB
TR11 4TA
|
|
Applicant Contact |
Wendy Hassan |
Correspondent |
RESEARCH INSTRUMENTS LIMITED |
BICKLAND INDUSTRIAL PARK |
FALMOUTH,
GB
TR11 4TA
|
|
Correspondent Contact |
Wendy Hassan |
Regulation Number | 884.6130
|
Classification Product Code |
|
Date Received | 05/06/2016 |
Decision Date | 01/23/2017 |
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
|
|
|