FDA 510(k) Application Details - K965037

Device Classification Name Endoscopic Cytology Brush

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510(K) Number K965037
Device Name Endoscopic Cytology Brush
Applicant MEDICAL DEVICE TECHNOLOGIES, INC.
9171 TOWNE CENTRE DR., #355
SAN DIEGO, CA 92122 US
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Contact RICHARD E SLOAN
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Regulation Number 876.1500

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Classification Product Code FDX
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Date Received 12/17/1996
Decision Date 01/08/1997
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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