FDA 510(k) Application Details - K990034

Device Classification Name Stent, Colonic, Metalic, Expandable

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510(K) Number K990034
Device Name Stent, Colonic, Metalic, Expandable
Applicant MED INSTITUTE, INC.
1400 CUMBERLAND AVE.
P.O. BOX 2402
WEST LAFAYETTE, IN 47906 US
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Contact NEAL E FEARNOT
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Regulation Number 878.3610

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Classification Product Code MQR
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Date Received 01/06/1999
Decision Date 04/17/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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