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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 K960004
Device Name CELL RECOVERY SYSTEM
Applicant
MEDICAL DEVICE TECHNOLOGIES, INC.
9191 TOWNE CENTRE DR., #420
SAN DIEGO,  CA  92122
Applicant Contact M. LEE HULSEBUS
Correspondent
MEDICAL DEVICE TECHNOLOGIES, INC.
9191 TOWNE CENTRE DR., #420
SAN DIEGO,  CA  92122
Correspondent Contact M. LEE HULSEBUS
Regulation Number876.1500
Classification Product Code
FDX  
Date Received01/02/1996
Decision Date 03/20/1996
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
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