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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocautery, gynecologic (and accessories)
510(k) Number K121881
Model G1
Device Name DOMAIN SURGICAL SYSTEM
Original Applicant
DOMAIN SURGICAL, INC.
1370 south 2100 east
salt lake sity,  UT  84108
Original Contact curtis jensen
Regulation Number884.4120
Classification Product Code
HGI  
Date Received06/26/2012
Decision Date 10/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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