FDA 510(k) Application Details - K971906

Device Classification Name Tube, Feeding

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510(K) Number K971906
Device Name Tube, Feeding
Applicant BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK, MA 01760-1537 US
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Contact LISA M QUAGLIA
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Regulation Number 876.5980

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Classification Product Code FPD
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Date Received 05/23/1997
Decision Date 08/20/1997
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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