FDA 510(k) Application Details - K993884

Device Classification Name Micromanipulators And Microinjectors, Assisted Reproduction

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510(K) Number K993884
Device Name Micromanipulators And Microinjectors, Assisted Reproduction
Applicant INTL., INC.
170 FORT PATH RD.
UNIT 14
MADISON, CT 06443 US
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Contact MICHAEL D CECCHI
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Regulation Number 884.6150

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Classification Product Code MQJ
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Date Received 11/16/1999
Decision Date 02/14/2000
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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