FDA 510(k) Application Details - K102273

Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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510(K) Number K102273
Device Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN, UT 84095 US
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Contact DAN W LINDSAY
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Regulation Number 876.4300

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Classification Product Code KNS
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Date Received 08/11/2010
Decision Date 09/07/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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