FDA 510(k) Application Details - K993342

Device Classification Name Instrument, Biopsy

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510(K) Number K993342
Device Name Instrument, Biopsy
Applicant WINDY HILL TECHNOLOGY, INC.
1010 HAMILTON COURT
MENLO COURT, CA 94025 US
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Contact ANGELA B SOITO
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Regulation Number 876.1075

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Classification Product Code KNW
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Date Received 10/05/1999
Decision Date 12/23/1999
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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