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FDA 510(k) Application Details - K161275
Device Classification Name
Microtools, Assisted Reproduction (Pipettes)
More FDA Info for this Device
510(K) Number
K161275
Device Name
Microtools, Assisted Reproduction (Pipettes)
Applicant
RESEARCH INSTRUMENTS LIMITED
BICKLAND INDUSTRIAL PARK
FALMOUTH TR11 4TA GB
Other 510(k) Applications for this Company
Contact
Wendy Hassan
Other 510(k) Applications for this Contact
Regulation Number
884.6130
More FDA Info for this Regulation Number
Classification Product Code
MQH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/06/2016
Decision Date
01/23/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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