FDA 510(k) Application Details - K012883

Device Classification Name Prosthesis, Esophageal

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510(K) Number K012883
Device Name Prosthesis, Esophageal
Applicant BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick, MA 01760 US
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Contact KATHLEEN MORAHAN
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Regulation Number 878.3610

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Classification Product Code ESW
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Date Received 08/28/2001
Decision Date 10/12/2001
Decision SESU - SE - WITH LIMITATIONS
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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