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FDA 510(k) Application Details - K133257
Device Classification Name
Microtools, Assisted Reproduction (Pipettes)
More FDA Info for this Device
510(K) Number
K133257
Device Name
Microtools, Assisted Reproduction (Pipettes)
Applicant
RESEARCH INSTRUMENTS LTD.
BICKLAND WATER INDUSTRIAL PARK
FALMOUTH
CORNWALL TR 11 4TA GB
Other 510(k) Applications for this Company
Contact
DAVID LANSDOWNE
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
10/23/2013
Decision Date
05/16/2014
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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