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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 K991261
Device Name ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET
Applicant
RESEARCH INSTRUMENTS LTD.
KERNICK RD.
PENRYN, CORWALL,  GB TR 10 9DQ
Applicant Contact DAVID C LANSDOWNE
Correspondent
RESEARCH INSTRUMENTS LTD.
KERNICK RD.
PENRYN, CORWALL,  GB TR 10 9DQ
Correspondent Contact DAVID C LANSDOWNE
Regulation Number884.6130
Classification Product Code
MQH  
Date Received04/13/1999
Decision Date 08/05/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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