FDA 510(k) Application Details - K022286

Device Classification Name Instrument, Biopsy

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510(K) Number K022286
Device Name Instrument, Biopsy
Applicant VIVANT MEDICAL, INC.
1916-A OLD MIDDLEFIELD WAY
MOUNTAIN VIEW, CA 94043 US
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Contact STEVEN KIM
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Regulation Number 876.1075

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Classification Product Code KNW
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Date Received 07/15/2002
Decision Date 10/11/2002
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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