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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, unipolar (and accessories)
510(k) Number K121343
Device Name MODULAP LOOP
Applicant
ATC TECHNOLOGIES, INC.
79 HAVEN STREET
DOVER,  MA  02030
Applicant Contact JOHN GILLESPIE
Correspondent
ATC TECHNOLOGIES, INC.
79 HAVEN STREET
DOVER,  MA  02030
Correspondent Contact JOHN GILLESPIE
Regulation Number884.4160
Classification Product Code
KNF  
Date Received05/04/2012
Decision Date 06/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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