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FDA 510(k) Application Details - K101832
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
876.1075
More FDA Info for this Regulation Number
Classification Product Code
KNW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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