FDA 510(k) Application Details - K133257

Device Classification Name Microtools, Assisted Reproduction (Pipettes)

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510(K) Number K133257
Device Name Microtools, Assisted Reproduction (Pipettes)
Applicant RESEARCH INSTRUMENTS LTD.
BICKLAND WATER INDUSTRIAL PARK
FALMOUTH
CORNWALL TR 11 4TA GB
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Contact DAVID LANSDOWNE
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Regulation Number 884.6130

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Classification Product Code MQH
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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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