FDA 510(k) Application Details - K103692

Device Classification Name Insufflator, Laparoscopic

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510(K) Number K103692
Device Name Insufflator, Laparoscopic
Applicant SURGIQUEST, INC.
12 CASCADE BLVD.
SUITE 2B
ORANGE, CT 06477 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 12/17/2010
Decision Date 05/25/2011
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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