FDA 510(k) Application Details - K983325

Device Classification Name Device, Cystometric, Hydraulic

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510(K) Number K983325
Device Name Device, Cystometric, Hydraulic
Applicant INFLUENCE, INC.
71 STEVENSON ST., SUITE 1120
SAN FRANCISCO, CA 94105 US
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Contact PETER A BICK
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Regulation Number 876.1620

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Classification Product Code FEN
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Date Received 09/22/1998
Decision Date 11/24/1998
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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