FDA 510(k) Application Details - K152843

Device Classification Name Electrocautery, Gynecologic (And Accessories)

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510(K) Number K152843
Device Name Electrocautery, Gynecologic (And Accessories)
Applicant LIGER MEDICAL, LLC
14062 S RUNNING CREEK WAY
DRAPER, UT 84020 US
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Contact STEVE SMITH
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Regulation Number 884.4120

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Classification Product Code HGI
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Date Received 09/29/2015
Decision Date 06/24/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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