FDA 510(k) Application Details - K142258

Device Classification Name Snare, Flexible

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510(K) Number K142258
Device Name Snare, Flexible
Applicant Medi-Globe Corporation
110 West Orion Street
Tempe, AZ 85283 US
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Contact Scott Karler
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Regulation Number 876.4300

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Classification Product Code FDI
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Date Received 08/14/2014
Decision Date 09/30/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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