FDA 510(k) Application Details - K143404

Device Classification Name Insufflator, Laparoscopic

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510(K) Number K143404
Device Name Insufflator, Laparoscopic
Applicant SURGIQUEST, INC.
333 Quarry Rd
Milford, CT 06460 US
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Contact Daniel Donovan
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Regulation Number 884.1730

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Classification Product Code HIF
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Date Received 11/28/2014
Decision Date 03/20/2015
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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