FDA 510(k) Application Details - K070759

Device Classification Name Instrument, Biopsy, Mechanical, Gastrointestinal

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510(K) Number K070759
Device Name Instrument, Biopsy, Mechanical, Gastrointestinal
Applicant VIDACARE CORPORATION
3722 AVE. SAUSALITO
IRVINE, CA 92606 US
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Contact GRACE HOLLAND
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Regulation Number 876.1075

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Classification Product Code FCF
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Date Received 03/20/2007
Decision Date 05/21/2007
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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