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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 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 Number884.6130
Classification Product Code
MQH  
Date Received05/06/2016
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
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