FDA 510(k) Application Details - K101832

Device Classification Name Instrument, Biopsy

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510(K) Number K101832
Device Name Instrument, Biopsy
Applicant MEDICAL DEVICE TECHNOLOGIES, INC.
3600 S.W. 47TH AVE.
GAINESVILLE, FL 32608 US
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Contact TRUDY D ESTRIDGE
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Regulation Number 876.1075

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Classification Product Code KNW
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Date Received 07/01/2010
Decision Date 08/27/2010
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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