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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name microtools, assisted reproduction (pipettes)
510(k) Number K133257
Device Name BIOPSY PIPETTES
Applicant
RESEARCH INSTRUMENTS LTD.
BICKLAND WATER INDUSTRIAL PARK
FALMOUTH
CORNWALL,  GB TR 11 4TA
Applicant Contact DAVID LANSDOWNE
Correspondent
RESEARCH INSTRUMENTS LTD.
BICKLAND WATER INDUSTRIAL PARK
FALMOUTH
CORNWALL,  GB TR 11 4TA
Correspondent Contact DAVID LANSDOWNE
Regulation Number884.6130
Classification Product Code
MQH  
Date Received10/23/2013
Decision Date 05/16/2014
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
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