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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name coagulator-cutter, endoscopic, bipolar (and accessories)
510(k) Number K113080
Model 3310
Device Name TUBALGATOR
Original Applicant
MECTRA LABS, INC.
two quality way
bloomfield,  IN  47424
Original Contact charles e allgood
Regulation Number884.4150
Classification Product Code
HIN  
Date Received10/18/2011
Decision Date 06/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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