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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K102273
Device Name MERIT BIPOLAR COAGULATION PROBE
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN,  UT  84095
Applicant Contact DAN W LINDSAY
Correspondent
MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN,  UT  84095
Correspondent Contact DAN W LINDSAY
Regulation Number876.4300
Classification Product Code
KNS  
Date Received08/11/2010
Decision Date 09/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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