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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K141484
Device Name OPEN FMSEALER
Applicant
DOMAIN SURGICAL, INC.
1370 SOUTH 2100 EAST
SALT LAKE SITY,  UT  84108
Applicant Contact CURTIS JENSEN
Correspondent
DOMAIN SURGICAL, INC.
1370 SOUTH 2100 EAST
SALT LAKE SITY,  UT  84108
Correspondent Contact CURTIS JENSEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/05/2014
Decision Date 07/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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