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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
Device Name TUBALGATOR
Applicant
MECTRA LABS, INC.
TWO QUALITY WAY
BLOOMFIELD,  IN  47424
Applicant Contact CHARLES E ALLGOOD
Correspondent
MECTRA LABS, INC.
TWO QUALITY WAY
BLOOMFIELD,  IN  47424
Correspondent Contact CHARLES E ALLGOOD
Regulation Number884.4150
Classification Product Code
HIN  
Date Received10/18/2011
Decision Date 06/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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