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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Cytology Brush
510(k) Number K965037
Device Name CELL RECOVERY SYSTEM
Applicant
MEDICAL DEVICE TECHNOLOGIES, INC.
9171 TOWNE CENTRE DR., #355
SAN DIEGO,  CA  92122
Applicant Contact RICHARD E SLOAN
Correspondent
MEDICAL DEVICE TECHNOLOGIES, INC.
9171 TOWNE CENTRE DR., #355
SAN DIEGO,  CA  92122
Correspondent Contact RICHARD E SLOAN
Regulation Number876.1500
Classification Product Code
FDX  
Date Received12/17/1996
Decision Date 01/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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