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FDA 510(k) Application Details - K172516
Device Classification Name
Insufflator, Laparoscopic
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510(K) Number
K172516
Device Name
Insufflator, Laparoscopic
Applicant
ConMed Corporation
488 Wheelers Farms Road
Milford, CT 06461 US
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Contact
Lisa Anderson
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Regulation Number
884.1730
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Classification Product Code
HIF
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More FDA Info for this Product Code
Date Received
08/21/2017
Decision Date
03/16/2018
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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